FDA 510(k) Applications for Medical Device Product Code "DYB"
(Introducer, Catheter)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K092097 | A.B. KORKOR MEDICAL, INC. | A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH | 05/06/2010 |
| K060902 | ABBOTT VASCULAR INC. | STARCLOSE INTRODUCER SET MODEL- 1002 | 07/07/2006 |
| K822834 | ACCESS DEVICES, INC. | ACCESS PERCUTANEOUS INTRODUCER SET | 11/01/1982 |
| K101150 | ACCESS SCIENTIFIC, INC. | PICC WAND PEELABLE SAFETY INTRODUCER | 08/13/2010 |
| K111138 | ACCESS SCIENTIFIC, INC. | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER | 06/22/2011 |
| K093022 | ACCESS SCIENTIFIC, INC. | THE PICC WAND PEELABLE SAFETY INTRODUCER | 01/20/2010 |
| K101422 | ACCESS SCIENTIFIC, INC. | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | 03/22/2011 |
| K111417 | ACCESS SCIENTIFIC, INC. | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | 07/15/2011 |
| K121748 | ACCESS SCIENTIFIC, INC. | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL | 07/27/2012 |
| K090372 | ACCESS SCIENTIFIC, INC. | THE WAND MICROACCESS SAFETY INTRODUCER | 03/30/2009 |
| K081697 | ACCESS SCIENTIFIC, INC. | THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 | 12/04/2008 |
| K131148 | ACCESS SCIENTIFIC, LLC | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH | 09/04/2013 |
| K182243 | Access Scientific, LLC | The CVC WAND Safety Introducer with Valved Peelable Sheath | 09/18/2018 |
| K131300 | ACCESS SCIENTIFIC, LLC | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | 06/07/2013 |
| K183066 | Access Scientific, LLC | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C« with BioGUARDÖ Technology-3 Fr, 4 Fr, and 5 Fr Model | 07/25/2019 |
| K162322 | ACCESS SCIENTIFIC, LLC | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | 11/17/2016 |
| K070197 | ACUMEN MEDICAL, INC. | ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY | 02/23/2007 |
| K042376 | ACUMEN MEDICAL, INC. | ACUMEN SHEATH, MODEL TTW7807 | 10/26/2004 |
| K053400 | ACUMEN MEDICAL, INC. | ACUMEN SINGLE-LUMEN DELIVERY SHEATH | 06/19/2006 |
| K080500 | ACUMEN MEDICAL, INC. | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 | 03/13/2008 |
| K070396 | ACUMEN MEDICAL, INC. | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 | 05/22/2007 |
| K083855 | ACUMEN MEDICAL, INC. | MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 | 02/17/2009 |
| K062145 | ACUMEN MEDICAL, INC. | MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 | 08/23/2006 |
| K051515 | ACUMEN MEDICAL, INC. | MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 | 09/01/2005 |
| K050015 | ACUMEN MEDICAL, INC. | MODIFIED ACUMEN SHEATH, MODEL TTWO767 | 02/03/2005 |
| K171557 | Acutus Medical, Inc. | AcQRef Introducer Sheath | 02/06/2018 |
| K192106 | Acutus Medical, Inc. | AcQRef Introducer Sheath | 09/03/2019 |
| K983940 | ADAM SPENCE CORP. | EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR | 07/15/1999 |
| K875158 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS FUNNEL INTRODUCER | 05/31/1988 |
| K934624 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE | 04/13/1994 |
| K830829 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | CORONARY GUIDING CATHETER | 04/28/1983 |
| K821188 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | INTRODUCER SET | 07/08/1982 |
| K113849 | ALSEAL | HQS INTRODUCER | 07/31/2012 |
| K153494 | ALSEAL | HQS Introducer (Model 2064-HQS) | 08/25/2016 |
| K133296 | ALSEAL | XCATH | 02/14/2014 |
| K800580 | ALVA MEDICAL, INC. | PERCUTANEOUS CATHETER INTRODUCER | 04/02/1980 |
| K131144 | AMECO MEDICAL INDUSTRIES | AMECO SHEATH INTRODUCER | 08/15/2013 |
| K894446 | ANGEION CORP. | ANGEION HEMOSTASIS VALVE INTRODUCER | 11/30/1989 |
| K871153 | ANGEION CORP. | CATHETER INTRODUCER | 06/24/1987 |
| K895580 | ANGEION CORP. | Y-ADAPTER W/THOUY BORST | 04/30/1990 |
| K040728 | ANGIODYNAMICS, INC. | ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT | 06/18/2004 |
| K170775 | AngioDynamics, Inc. | Mini Stick ENVI Non-Vascular Introducer Kit | 07/19/2017 |
| K964034 | ANGIODYNAMICS, INC. | TRANSJUGULAR ACCESS SET | 05/06/1997 |
| K170695 | AngioDynamics, Inc. | VenaCure EVLT NeverTouch Direct Introducer Sheath | 05/30/2017 |
| K861238 | ANGIOMEDICS, INC. | ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV | 07/16/1986 |
| K873195 | ANGIOMEDICS, INC. | SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO | 12/15/1987 |
| K070865 | APPLIED MEDICAL | EXPANDING VASCULAR SHEATH | 10/23/2007 |
| K963886 | APPLIED MEDICAL RESOURCES | EVS | 04/24/1997 |
| K041506 | APPLIED MEDICAL RESOURCES CORP. | INTRAVASCULAR ACCESS INTRODUCER SHEATH | 10/15/2004 |
| K063658 | APPLIED MEDICAL RESOURCES CORP. | INTRAVASCULAR INTRODUCER SYSTEM | 09/12/2007 |
| K890766 | APPLIED VASCULAR DEVICES, INC. | CATHETER INTRODUCER SHEATH | 09/18/1989 |
| K895214 | APPLIED VASCULAR DEVICES, INC. | HEMOSTASIS VALVE | 11/14/1989 |
| K012489 | APPRIVA MEDICAL, INC. | MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 | 08/30/2001 |
| K002054 | APPRIVA MEDICAL, INC. | X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 | 02/16/2001 |
| K130730 | ARGON MEDICAL | V-STICK VASCULAR ACCESS SET | 11/22/2013 |
| K891022 | ARGON MEDICAL CORP. | INTRODUCER FOR PTCA GUIDING CATHETERS | 05/19/1989 |
| K894157 | ARGON MEDICAL CORP. | OBTURATOR | 09/28/1989 |
| K882221 | ARGON MEDICAL CORP. | OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE | 08/12/1988 |
| K852880 | ARGON MEDICAL CORP. | PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) | 08/29/1985 |
| K141969 | ARGON MEDICAL DEVICES, INC | FIRSTSTIC N INTRODUCER | 12/19/2014 |
| K871140 | ARIES MEDICAL, INC. | ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER | 04/22/1987 |
| K870189 | ARIES MEDICAL, INC. | ARIES TAPERED SHEATH | 03/16/1987 |
| K903442 | ARIES MEDICAL, INC. | ARIES TAPERSEAL(TM) SHEATH | 08/23/1990 |
| K842004 | ARIES MEDICAL, INC. | PERCUTANEOUS CATHETER INTRODUCER SET | 07/13/1984 |
| K122854 | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER | 01/04/2013 |
| K924607 | ARROW INTL., INC. | ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET | 04/22/1993 |
| K940079 | ARROW INTL., INC. | ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 | 11/30/1994 |
| K970229 | ARROW INTL., INC. | ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET | 02/13/1998 |
| K840455 | ARROW INTL., INC. | EMERGENCY INFUSION DEVICE | 05/23/1984 |
| K981782 | ARROW INTL., INC. | LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM | 08/12/1998 |
| K011761 | ARROW INTL., INC. | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT | 10/31/2001 |
| K780532 | ARROW INTL., INC. | PERCUTANEOUS SHEATH INTRODUCER KIT | 04/21/1978 |
| K021723 | ARROW INTL., INC. | SHEATH ADAPTER, MODEL SA-09847 | 08/08/2002 |
| K002507 | ARROW INTL., INC. | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT | 03/21/2001 |
| K100615 | ARSTASIS, INC. | ARSTASIS ACCESS SYSTEM | 03/30/2010 |
| K102728 | ARSTASIS, INC. | ARSTASIS ACCESS SYSTEM | 10/07/2010 |
| K103143 | ARSTASIS, INC. | ARSTASIS ONE LATCHWIRE ACCESS SYSTEM | 02/02/2011 |
| K132263 | ARSTASIS, INC. | AXERA 2 ACCESS SYSTEM | 08/19/2013 |
| K123618 | ARSTASIS, INC. | AXERA 2 ACCESS SYSTEM | 03/24/2013 |
| K140871 | ARSTASIS, INC. | AXERA 2 ACCESS SYSTEM | 06/06/2014 |
| K140201 | ARSTASIS, INC. | AXERA 2 ACCESS SYSTEM | 03/28/2014 |
| K123135 | ARSTASIS, INC. | AXERA 2 ACCESS SYSTEM MODEL AXE200 | 01/28/2013 |
| K113110 | ARSTASIS, INC. | AXERA ACCESS SYSTEM | 11/09/2011 |
| K121521 | ARSTASIS, INC. | AXERA ACCESS SYSTEM | 06/21/2012 |
| K140287 | ARSTASIS, INC. | AXERA RX ACCESS SYSTEM | 05/16/2014 |
| K091006 | ARSTASIS, INC. | ITG VASCULAR ACCESS SYSTEM, MODEL 300 | 02/25/2010 |
| K930057 | B. BRAUN MEDICAL, INC. | ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET | 08/06/1993 |
| K960406 | B. BRAUN MEDICAL, INC. | BRAUN HEMOSTASIS INTRODUCERS | 04/12/1996 |
| K955820 | B. BRAUN MEDICAL, INC. | BRAUN HEMOSTASIS INTRODUCERS | 03/25/1996 |
| K961745 | B. BRAUN MEDICAL, INC. | BRAUN PERCUTANEOUS INTRODUCER SET | 09/17/1996 |
| K931743 | B. BRAUN MEDICAL, INC. | BURRON CARDIOVASCULAR ANGESTAT(TM) | 11/02/1993 |
| K945396 | B. BRAUN MEDICAL, INC. | FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET | 03/13/1995 |
| K033527 | B. BRAUN MEDICAL, INC. | INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER | 02/05/2004 |
| K021094 | B. BRAUN MEDICAL, INC. | INTROCAN SAFETY IV CATHETER | 07/03/2002 |
| K030135 | B. BRAUN MEDICAL, INC. | SAFETY INTRODUCER NEEDLE | 07/15/2003 |
| K915421 | B. BRAUN OF AMERICA, INC. | GUIDEWIRE INTRODUCER SET | 02/27/1992 |
| K981909 | BAXTER EDWARDS | BAXTER HEMOSTASIS VALVE INTRODUCERS | 11/24/1998 |
| K885179 | BAXTER HEALTHCARE CORP. | INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD | 08/09/1989 |
| K122926 | BAYLIS MEDICAL CO., INC. | SUREFLEX STEERABLE GUIDING SHEATH KIT | 01/24/2013 |
| K102948 | BAYLIS MEDICAL CO., INC. | TORFLEX TRANSSEPTAL GUIDING SHEATH | 04/01/2011 |
| K191546 | Baylis Medical Company Inc. | Epicardial Access System | 08/02/2019 |
| K190688 | Baylis Medical Company Inc. | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | 04/17/2019 |
| K183655 | Baylis Medical Company Inc. | VersaCross Transseptal Sheath | 05/20/2019 |
| K020834 | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I | 06/12/2002 |
| K954906 | BECTON DICKINSON VASCULAR ACCESS, INC. | FIRST PICC INTRODUCER CATHETER | 04/08/1996 |
| K903410 | BIO MEDICUS, INC. | BIO-MEDICUS CANNULA INTRODUCER | 10/31/1990 |
| K190941 | BioCardia, Inc. | BioCardia 8.5 F Avance Steerable lntroducer | 05/06/2019 |
| K090999 | BIOCARDIA, INC. | BIOCARDIA MORPH SHEATH GUIDE | 04/15/2009 |
| K170997 | Biosense Webster, Inc. | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | 07/25/2017 |
| K001139 | BIOSENSE WEBSTER, INC. | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M | 05/10/2000 |
| K073434 | BIPORE, INC. | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | 04/01/2008 |
| K051513 | BIPORE, INC. | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | 12/07/2005 |
| K964814 | BIPORE, INC. | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | 05/07/1997 |
| K190184 | Boston Scientific | iSLEEVE Introducer Set | 03/07/2019 |
| K930808 | BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES | PROTECTOR INTRODUCER SHEATH | 03/15/1994 |
| K920528 | BOSTON SCIENTIFIC CORP. | CATHETER INTRODUCER | 08/12/1992 |
| K150186 | BOSTON SCIENTIFIC CORP. | Chariot Guiding Sheath | 06/05/2015 |
| K072719 | BOSTON SCIENTIFIC CORP. | CONVOY ADVANCED DELIVERY SHEATH | 03/07/2008 |
| K992309 | BOSTON SCIENTIFIC CORP. | INTRODUCER SHEATH, VESSEL DILATOR | 10/07/1999 |
| K994252 | BOSTON SCIENTIFIC CORP. | INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE | 01/04/2000 |
| K891121 | BOSTON SCIENTIFIC CORP. | MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM | 12/05/1989 |
| K952828 | BOSTON SCIENTIFIC CORP. | MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM | 08/18/1995 |
| K034061 | BOSTON SCIENTIFIC CORP. | MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH | 01/30/2004 |
| K191871 | Boston Scientific Corporation | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set | 08/07/2019 |
| K180785 | Boston Scientific Corporation | iSLEEVE Introducer Set | 06/22/2018 |
| K140641 | Boston Scientific Corporation | VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA | 07/03/2014 |
| K161183 | C.R. BARD, INC | Halo One Thin-Walled Guiding Sheath | 06/03/2016 |
| K042036 | C.R. BARD, INC. | AIRGUARD VALVED INTRODUCER | 08/23/2004 |
| K781954 | C.R. BARD, INC. | CATHETER INTRODUCERS, ARTERISE | 11/29/1978 |
| K897041 | C.R. BARD, INC. | HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS | 03/16/1990 |
| K961135 | C.R. BARD, INC. | INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) | 04/30/1996 |
| K960445 | C.R. BARD, INC. | INPUT TUOHY-BORST LOCKING DEVICE | 08/12/1996 |
| K162769 | C.R. BARD, INC. | Pinpoint GT Introducer Needle | 11/04/2016 |
| K142445 | C.R. BARD, INC. | PINPOINT GT SAFETY INTRODUCER NEEDLE | 04/13/2015 |
| K955785 | C.R. BARD, INC. | TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET | 03/12/1996 |
| K920251 | C.R. BARD, INC. | USCI HEMAQUET XT INTRODUCER | 03/18/1992 |
| K791963 | C.R. BARD, INC. | USCI MULLINS TRANSSEPTAL CATHETER INTRO. | 11/13/1979 |
| K901452 | C.R. BARD, INC. | USCI(R) ACCESS(TM) INTRODUCER SET | 05/22/1990 |
| K915553 | C.R. BARD, INC. | USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING | 02/21/1992 |
| K884104 | C.R. BARD, INC. | USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR | 12/21/1988 |
| K853072 | CAMINO LABORATORIES, INC. | CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 | 12/09/1985 |
| K950155 | CARDIO VASCULAR CONCEPTS, INC. | RAPID-TRAK(TM) INTRODUCER SHEATH | 08/02/1995 |
| K863917 | CARDIO-VASCULAR INNOVATIONS, INC. | CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. | 01/06/1987 |
| K843500 | CARDIO-VASCULAR INNOVATIONS, INC. | FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN | 10/18/1984 |
| K140015 | CARDIOSOLUTIONS INC | CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER | 02/05/2014 |
| K131332 | CARDIOSOLUTIONS INC | CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER | 07/19/2013 |
| K843118 | CARDIOVASCULAR RESEARCH, INC. | CANNULA INTRODUCER | 11/13/1984 |
| K790034 | CLINCAL INSTRUMENTS CORP. | INTRODUCERS | 02/01/1979 |
| K853100 | COBE LABORATORIES, INC. | COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT | 09/25/1985 |
| K142357 | CONTRACT MEDICAL INTERNATIONAL GMBH | DuraSheath Introducer Sheath System | 06/25/2015 |
| K181463 | Contract Medical International GmbH | DuraSheath Introducer Sheath System | 12/13/2018 |
| K153197 | CONTRACT MEDICAL INTERNATIONAL GMBH | Fortress Introducer Sheath SYstem | 01/11/2016 |
| K100799 | CONTRACT MEDICAL INTL. GMBH | FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 | 02/25/2011 |
| K171609 | Cook Incorporated | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | 06/04/2018 |
| K123235 | COOK INCORPORATED | EQUAFLOW MULTIVALVE INFUSION CATHETER | 02/14/2013 |
| K152044 | COOK INCORPORATED | Flexor Radial Hydrophilic Introducer Access Set | 08/14/2015 |
| K142829 | Cook Incorporated | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Co | 07/28/2015 |
| K153430 | COOK INCORPORATED | Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select | 03/07/2016 |
| K171853 | Cook Incorporated | Liver Access and Biopsy Sets | 08/24/2017 |
| K133114 | COOK INCORPORATED | MICROPUNCTURE INTRODUCER SET | 07/03/2014 |
| K171275 | Cook Incorporated | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design | 12/20/2017 |
| K172980 | Cook Incorporated | Micropuncture Pedal Access Set | 05/03/2018 |
| K173685 | Cook Incorporated | Peel-Away Introducer Set | 12/20/2017 |
| K170020 | Cook Incorporated | Peel-Away Introducer Set | 09/28/2017 |
| K171988 | Cook Incorporated | Performer Guiding Sheath | 03/30/2018 |
| K173068 | COOK Incorporated | Performer Introducer | 11/17/2017 |
| K171999 | Cook Incorporated | Performer Introducer | 07/31/2017 |
| K142819 | COOK INCORPORATED | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set | 07/24/2015 |
| K171820 | Cook Incorporated | Transjugular Liver Access Sets | 03/09/2018 |
| K010128 | COOK VASCULAR, INC. | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE | 04/25/2002 |
| K023937 | COOK VASCULAR, INC. | COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM | 05/27/2003 |
| K895044 | COOK, INC. | DUAL GUIDE INTRODUCER CATHETER | 02/26/1990 |
| K132592 | COOK, INC. | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET | 10/09/2014 |
| K001985 | COOK, INC. | INTRODEUCE DOUBLE LUMEN INTRODUCER | 01/25/2001 |
| K001135 | CORDIS CORP. | 6F & 7F INTRODUCING CATHETERS (MODIFICATION) | 07/03/2000 |
| K911794 | CORDIS CORP. | CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE | 07/19/1991 |
| K945616 | CORDIS CORP. | CORDIS AVANTI CATHETER SHEATH INTRODUCER | 03/29/1995 |
| K962746 | CORDIS CORP. | CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT | 10/11/1996 |
| K974448 | CORDIS CORP. | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | 02/06/1998 |
| K984500 | CORDIS CORP. | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | 12/23/1998 |
| K971608 | CORDIS CORP. | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | 07/21/1997 |
| K954595 | CORDIS CORP. | CORDIS BRITE TIP SHEATH INTRODUCER | 12/28/1995 |
| K913801 | CORDIS CORP. | CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL | 10/16/1991 |
| K861082 | CORDIS CORP. | CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST | 05/05/1986 |
| K932733 | CORDIS CORP. | CORDIS CATHETER SHEATH INTRODUCER | 08/26/1993 |
| K855126 | CORDIS CORP. | CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES | 02/26/1986 |
| K945524 | CORDIS CORP. | CORDIS INTRODUCING CATHETER | 04/26/1995 |
| K931102 | CORDIS CORP. | CORDIS NIHON CATHETER SHEATH INTRODUCER | 05/27/1993 |
| K914352 | CORDIS CORP. | CORDIS OBTURATOR | 11/22/1991 |
| K910688 | CORDIS CORP. | CORDIS PEEL-AWAY INSERTION TOOL | 05/16/1991 |
| K904475 | CORDIS CORP. | ENTREE SHEATH INTRODUCER SYSTEM | 04/01/1991 |
| K983023 | CORDIS CORP. | MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | 10/01/1998 |
| K851947 | CORDIS CORP. | PTCA GUIDING CATHETER | 08/16/1985 |
| K180081 | Cordis Corporation | RAILWAY Sheathless Access System | 04/18/2018 |
| K181592 | Cordis Corporation | RAIN Sheath Transradial | 08/15/2018 |
| K970264 | CORDIS WEBSTER, INC. | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | 10/28/1997 |
| K982740 | CORDIS WEBSTER, INC. | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S | 08/28/1998 |
| K860432 | CORMED, INC., SUB. C.R.BARD, INC. | PERCUTANEOUS INTRODUCER KIT | 03/31/1986 |
| K152913 | CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle | 07/21/2016 |
| K131079 | CREGANNA MEDICAL DEVICES | CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC | 08/01/2013 |
| K140338 | CREGANNA-TACTX MEDICAL | CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) | 08/27/2014 |
| K040552 | CRYOCOR, INC. | MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 | 05/28/2004 |
| K000004 | DAIG CORP. | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 | 11/29/2000 |
| K934285 | DAIG CORP. | CATHETER INTRODUCER MODIFICATION | 11/24/1993 |
| K920327 | DAIG CORP. | DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER | 04/16/1992 |
| K914090 | DAIG CORP. | DAIG FAST CATH(TM) INTRODUCER, MODIFICATION | 10/28/1991 |
| K884494 | DAIG CORP. | DAIG OBTURATOR, CATHETER INTRODUCER | 02/22/1989 |
| K894343 | DAIG CORP. | DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO | 09/26/1989 |
| K954317 | DAIG CORP. | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS | 11/28/1995 |
| K973840 | DAIG CORP. | FAST-CATH (TM) INTRA-CARDIAC INTRODUCER | 05/21/1998 |
| K920779 | DAIG CORP. | FAST-CATH HEMOSTASIS INTRODUCER | 06/03/1992 |
| K982187 | DAIG CORP. | FAST-CATH INTRA-CARDIAC INTRODUCER | 09/16/1998 |
| K964518 | DAIG CORP. | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER | 05/14/1997 |
| K894430 | DAIG CORP. | MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY | 08/09/1989 |
| K910861 | DAIG CORP. | PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK | 05/07/1991 |
| K870374 | DAIG CORP. | PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK | 03/18/1987 |
| K800356 | DAIG CORP. | PERMANENT LEAD INTRADUCER | 05/28/1980 |
| K994334 | DAIG CORP. | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX | 05/15/2000 |
| K902932 | DATASCOPE CORP. | DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL | 10/16/1990 |
| K901391 | DATASCOPE CORP. | DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER | 06/26/1990 |
| K002365 | DATASCOPE CORP. | DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET | 08/25/2000 |
| K973007 | DATASCOPE CORP. | DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER | 11/06/1997 |
| K820834 | DATASCOPE CORP. | PERCOR PERCUTANEOUS INTRODUCER | 04/14/1982 |
| K903530 | DAVOL, INC. | PERCUTANEOUS INTRODUCERS | 10/22/1990 |
| K871132 | DELTEC SYSTEMS, INC. | PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS | 04/20/1987 |
| K883933 | DEVICES FOR VASCULAR INTERVENTION, INC. | INTRODUCING CATHETER | 12/02/1988 |
| K911678 | DEVICES FOR VASCULAR INTERVENTION, INC. | ROTATING HEMOSTATIC VALVE | 07/12/1991 |
| K911883 | DIAG CORP. | DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER | 11/29/1991 |
| K984062 | DIAG CORP. | SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 | 03/24/1999 |
| K812973 | DIP, INC. | PERCUTANEOUS INTRODUCER COURNAND STYLE | 11/16/1981 |
| K813019 | DIP, INC. | PERCUTANEOUS INTRODUCER: SELDINGER STYLE | 11/16/1981 |
| K840923 | DLP, INC. | ANGIOGRAPHY NEEDLE W/WO CONNECTION | 04/17/1984 |
| K914330 | E-Z-EM, INC. | SOS BLOODLESS NEEDLE | 12/20/1991 |
| K162184 | Edward Lifesciences | Edwards eSheath Introducer Set | 09/02/2016 |
| K152225 | EDWARDS LIFESCIENCES | Edwards eSheath Introducer Set | 11/24/2015 |
| K141696 | EDWARDS LIFESCIENCES | EDWARDS ESHEATH INTRODUCER SET | 09/18/2014 |
| K131627 | EDWARDS LIFESCIENCES, LLC. | CATHETER INTRODUCER SHEATH | 03/06/2014 |
| K123714 | EDWARDS LIFESCIENCES, LLC. | EDWARDS EMBOL-X INTRODUCER SHEATH | 07/24/2013 |
| K031087 | EDWARDS LIFESCIENCES, LLC. | EDWARDS INTRODUCER SHEATH | 04/24/2003 |
| K030944 | EDWARDS LIFESCIENCES, LLC. | EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL | 06/20/2003 |
| K014052 | EDWARDS LIFESCIENCES, LLC. | EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL | 03/08/2002 |
| K121185 | EDWARDS LIFESCIENCES, LLC. | EDWARDS PERCUTANEOUS SHEATH INTRODUCER | 08/22/2012 |
| K140398 | EDWARDS LIFESCIENCES, LLC. | EMBOL-X INTRODUCER SHEATH | 03/19/2014 |
| K093877 | EDWARDS LIFESCIENCES, LLC. | RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 | 07/01/2010 |
| K770427 | ELECTRO-CATHETER CORP. | CATHETER INTRODUCER KIT | 03/16/1977 |
| K002973 | EMBOL-X, INC. | EMBOL-X INTRODUCER, MODEL CF00200 | 04/26/2001 |
| K120212 | ENDOLOGIX, INC. | AFX INTRODUCER SYSTEM | 02/09/2012 |
| K110090 | ENDOLOGIX, INC. | AFX INTRODUCER SYSTEM | 05/26/2011 |
| K111747 | ENDOLOGIX, INC. | ENDOLOGIX AFX INTRODUCER SYSTEM | 07/12/2011 |
| K190098 | Endophys Holdings LLC | Endophys Pressure Sensing Sheath | 03/07/2019 |
| K180620 | Endophys Holdings, LLC | Endophys Pressure Sensing Sheath Kit | 10/12/2018 |
| K173399 | Endophys Holdings, LLC | Endophys Pressure Sensing Sheath Kit- 8F | 11/30/2017 |
| K141275 | ENDOPHYS, INC. | ENDOPHYS PRESSURE SENSING SHEATH KIT | 01/07/2015 |
| K160272 | Endophys, Inc. | Endophys Pressure Sensing Sheath Kit | 03/04/2016 |
| K041708 | ENPATH MEDICAL INCORPORATED | ENPATH SAFETY INTRODUCER | 11/30/2004 |
| K063182 | ENPATH MEDICAL, INC. | ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX | 12/21/2006 |
| K081394 | ENPATH MEDICAL, INC. | PTFE INTERLOCK PEELABLE INTRODUCERS | 09/15/2008 |
| K071574 | ENPATH MEDICAL, INC. | STIFFER COAXIAL MICRO-INTRODUCER KIT | 07/05/2007 |
| K072248 | ENPATH MEDICAL, INC. | VIAPEEL PEELABLE INTRODUCER | 11/09/2007 |
| K090867 | EP DYNAMICS, INC. | AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 | 07/30/2009 |
| K111603 | EP DYNAMICS, INC. | LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM | 08/23/2012 |
| K961513 | EP MEDSYSTEMS | PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET | 05/13/1996 |
| K170831 | EpiEP, INc | EpiAccess System | 05/09/2017 |
| K142245 | EpieP, Inc. | EpiAccess System | 10/29/2014 |
| K813143 | EXCO, INC. | DESILET | 11/27/1981 |
| K923681 | EXONIX RESEARCH CORP. | EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI | 01/21/1993 |
| K042308 | FACILE MEDICAL, INC. | SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 | 02/17/2005 |
| K093026 | FOOTPRINT MEDICAL | FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER | 02/24/2010 |
| K191190 | Freudenberg Medical LLC | Steerable Introducer | 08/01/2019 |
| K190628 | Freudenberg Medical MIS, Inc | FlexSeal Introducer Sheath with Hydrophilic Coating | 05/30/2019 |
| K112398 | GALT MEDICAL | TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT | 04/12/2012 |
| K043525 | GALT MEDICAL CORP. | CATHETER INTRODUCER | 02/09/2005 |
| K173287 | Galt Medical Corp. | Elite HV Radial | 12/21/2017 |
| K140028 | GALT MEDICAL CORP. | GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER | 08/21/2014 |
| K123430 | GALT MEDICAL CORP. | MICROSLIDER TEARAWAY INTRODUCER SET | 04/12/2013 |
| K153533 | GALT MEDICAL CORP. | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | 07/05/2016 |
| K970201 | GENERAL SURGICAL INNOVATIONS | GSI CANNULA WITH INTRODUCER | 04/21/1997 |
| K915167 | GESCO INTL., INC. | GESCO PER-Q-CATH CATHETER INTRODUCER | 01/27/1992 |
| K823262 | GOULD, INC. | MODEL SP5800 #8 FRENCH INTRO. KIT | 01/18/1983 |
| K130559 | Greatbatch Medical | MOBICATH BI-DIRECTIONAL GUIDING SHEATH | 05/24/2013 |
| K101784 | Greatbatch Medical | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX | 11/26/2010 |
| K093232 | Greatbatch Medical | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER | 03/15/2010 |
| K093023 | Greatbatch Medical | PTFE PEELABLE INTRODUCER | 10/29/2009 |
| K102540 | Greatbatch Medical | PTFE PORTABLE INTRODUCER | 11/16/2010 |
| K181855 | Greatbatch Medical | RadialSeal Introducer Kit | 07/26/2018 |
| K110051 | Greatbatch Medical | RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT | 02/02/2012 |
| K003889 | GUIDANT CARDIAC AND VASCULAR SURGERY | ANCURE SHEATH MODEL # 40315, 40320, 40325 | 01/24/2002 |
| K002676 | GUIDANT CARDIAC AND VASCULAR SURGERY | ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER | 10/30/2000 |
| K091367 | GUIDED DELIVERY SYSTEMS | GDS-DCS | 11/05/2009 |
| K882657 | HARBOR MEDICAL DEVICES, INC. | HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT | 12/13/1988 |
| K851078 | HDC CORP. | HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER | 04/19/1985 |
| K032404 | HDC CORP. | SELDINGER SAFETY NEEDLE INTRODUCER | 09/10/2003 |
| K972570 | HEARTPORT, INC. | HEARTPORT INTRODUCER SHEATH | 10/01/1997 |
| K860898 | INFUSAID CORP. | "SUBCLAVIAN INTRODUCER SET" | 04/29/1986 |
| K902251 | INFUSAID CORP. | SUBCLAVIAN INTRODUCER SET | 07/31/1990 |
| K040029 | INJECTIMED, INC. | SAFETYNET GUIDEWIRE INTRODUCER | 04/05/2004 |
| K931489 | INNERDYNE MEDICAL, INC. | INTHERM RADIALLY EXPANDING DILATING INTRODUCER | 10/15/1993 |
| K972684 | INNERDYNE, INC. | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM | 10/10/1997 |
| K980578 | INNERDYNE, INC. | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) | 09/11/1998 |
| K992668 | INNERDYNE, INC. | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) | 05/26/2000 |
| K903840 | INTEC MEDICAL, INC. | GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY | 10/16/1990 |
| K903906 | INTEC MEDICAL, INC. | PERCUTANEOUS CATHETER INTRODUCER KIT | 09/26/1990 |
| K030723 | INTEGRATED VASCULAR SYSTEMS, INC. | IVS INTRODUCER SET, MODEL 1003 | 04/03/2003 |
| K031583 | INTEGRATED VASCULAR SYSTEMS, INC. | MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 | 06/16/2003 |
| K903463 | INTENSIVE TECHNOLOGY, INC. | IVT INTRODUCER SHEATH | 01/03/1991 |
| K912664 | INTENSIVE TECHNOLOGY, INC. | TEC ROTATING DUAL HEMOVALVE | 08/24/1992 |
| K812502 | INTERMEDICS, INC. | IMPLANTAID LEAD INTRODUCER #319-10 & 12 | 10/13/1981 |
| K915625 | INTERVENTIONAL THERAPEUTICS CORP. | INTRODUCER CATHETER | 06/03/1992 |
| K900756 | INTERVENTIONAL THERAPEUTICS CORP. | ITC INTRODUCER CATHETER | 08/08/1990 |
| K072130 | INTROMED | PTFE PEEL AWAY MICROINTRODUCER | 10/31/2007 |
| K962978 | JOHNSON & JOHNSON MEDICAL, INC. | CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM | 01/07/1997 |
| K162427 | KALILA MEDICAL, INC. | Vado Bi-Directional Steerable Sheath | 01/27/2017 |
| K140420 | KALILA MEDICAL, INC. | VADO STEERABLE SHEATH | 04/01/2014 |
| K160721 | KALILA MEDICAL, INC. | Vado Steerable Sheath | 03/07/2017 |
| K923603 | KONTRON INSTRUMENTS, INC. | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION | 03/08/1993 |
| K123475 | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD | SHOOCIN INTRODUCER KIT | 02/03/2014 |
| K172099 | Lepu Medical Technology (Beijing) Co., Ltd. | Shoocin Introducer Kit | 10/05/2017 |
| K172331 | Lepu Medical Technology (Beijing) Co., Ltd. | Type I, Type II, Type III, Type IV | 03/02/2018 |
| K140768 | LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD. | TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT | 11/25/2014 |
| K161659 | LIBRA MEDICAL INC. | FlexSeal Introducer Sheath with Hydrophilic Coating | 07/15/2016 |
| K982797 | LUTHER MEDICAL PRODUCTS, INC. | BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB | 11/30/1998 |
| K924562 | LUTHER MEDICAL PRODUCTS, INC. | CATHETER INTRODUCER | 02/25/1993 |
| K845037 | MALLINCKRODT CRITICAL CARE | PERCUTANEOUS ANGIOGRAPHIC NEEDLES | 06/21/1985 |
| K894445 | MALLINCKROOT, INC. | MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE | 10/02/1989 |
| K884159 | MALLINCKROOT, INC. | SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT | 02/22/1989 |
| K101399 | MARTECH MEDICAL PRODUCTS | COAXIAL INTRODUCER SET | 06/17/2010 |
| K130855 | MARTECH MEDICAL PRODUCTS | PTFE SUPER SHEATH INTRODUCER | 07/29/2013 |
| K120617 | MARTECH MEDICAL PRODUCTS | PTFE SUPER SHEATH INTRODUCER | 11/19/2012 |
| K002847 | MAXXIM MEDICAL | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX | 05/31/2001 |
| K843798 | MEADOX SURGIMED, INC. | MEADOX SURGIMED A/S CATHETER SHEATH SYS | 12/27/1984 |
| K011085 | MEDAMICUS, INC. | GUIDEWIRE INTRODUCER SAFETY NEEDLE | 07/09/2001 |
| K924491 | MEDAMICUS, INC. | INTRODUCER, PERCUTANEOUS -- MODIFICATION | 11/18/1992 |
| K020563 | MEDAMICUS, INC. | MEDAMICUS AXIA RSN | 05/21/2002 |
| K990705 | MEDAMICUS, INC. | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET | 06/28/1999 |
| K030905 | MEDAMICUS, INC. | MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | 04/09/2003 |
| K951313 | MEDAMICUS, INC. | MEDAMICUS PERCUTANEOUS INTRODUCER | 06/27/1995 |
| K022689 | MEDAMICUS, INC. | MODIFICATION TO MEDAMICUS AXIA RSN | 08/23/2002 |
| K040150 | MEDAMICUS, INC. | MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | 02/18/2004 |
| K932323 | MEDAMICUS, INC. | PERCUTANEOUS INTRODUCER | 11/09/1993 |
| K893658 | MEDAMICUS, INC. | PERCUTANEOUS INTRODUCER | 08/03/1989 |
| K000824 | MEDAMICUS, INC. | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX | 04/13/2000 |
| K965167 | MEDAMICUS, INC. | PERCUTANEOUS VENOUS INTRODUCER 10264 | 07/25/1997 |
| K021004 | MEDAMICUS, INC. | VALVED PEELABLE INTRODUCER | 06/06/2002 |
| K944107 | MEDAMICUS, INC. | VIP PLUS PERCUTANEOUS INTRODUCER | 09/14/1994 |
| K053092 | MEDCOMP | MEDCOMP VASCU-SHEATH II | 08/01/2006 |
| K022513 | MEDCOMP | MEDCOMP VASCU-SHEATH INTRODUCER SET | 10/25/2002 |
| K091954 | MEDCOMP | MICRO-STICK SET | 01/08/2010 |
| K090394 | MEDCOMP | VALVED TEARWAY INTRODUCER | 09/01/2009 |
| K153246 | MEDCOMP (MEDICAL COMPONENTS, INC.) | PTFE Super Sheath Introducer 2.1 | 02/12/2016 |
| K132498 | MEDCOMP (MEDICAL COMPONENTS, INC.) | VALVED TEARAWAY INTRODUCER GENERATION II | 11/25/2013 |
| K870907 | MEDFUSION SYSTEMS, INC. | INTRODUCER, PERCUTANEOUS | 04/09/1987 |
| K130687 | MEDICAL COMPONENTS INC | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | 08/15/2013 |
| K124046 | MEDICAL COMPONENTS INC | VALVED TEARAWAY INTRODUCER GENERATION II | 06/03/2013 |
| K011790 | MEDICAL DEVICE TECHNOLOGIES, INC. | MICROCRUISER PLUS INTRODUCER SET | 09/05/2001 |
| K902477 | MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET | 08/24/1990 |
| K933522 | MEDIZIV MEDICAL PRODUCTS 1987 LTD. | INTRODUCER NEEDLE (SEVERAL SIZES) | 02/21/1995 |
| K163268 | Medtronic CryoCath LP | FlexCath Select Steerable Shealth and Dilator | 02/02/2017 |
| K142684 | Medtronic CryoCath LP | FlexCath Select Steerable Sheath (10 French) | 11/06/2014 |
| K132030 | MEDTRONIC INC. | MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING | 09/27/2013 |
| K162097 | Medtronic Vascular | InTRAkit | 11/17/2016 |
| K842780 | MEDTRONIC VASCULAR | MEDTRONIC 6210 PERMANENT LEAD INTRODUC | 08/03/1984 |
| K854559 | MEDTRONIC VASCULAR | MEDTRONIC PERMANENT LEAD INTRODUCER | 12/24/1985 |
| K911236 | MEDTRONIC VASCULAR | MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS | 06/18/1991 |
| K900515 | MEDTRONIC VASCULAR | MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) | 08/23/1990 |
| K123990 | MEDTRONIC VASCULAR | SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING | 04/26/2013 |
| K171866 | Medtronic Vascular, Inc. | Sentrant Introducer Sheath with Hydrophilic Coating | 12/20/2017 |
| K152054 | Medtronic, Inc. | Confida Adaptive Sheath | 08/07/2015 |
| K132617 | MEDTRONIC, INC. | MEDTRONIC INPUT PS INTRODUCER | 04/30/2014 |
| K930801 | MENLO CARE, INC. | INTROPEEL | 09/22/1993 |
| K931218 | MENLO CARE, INC. | INTROPEEL V | 09/22/1993 |
| K152116 | MERIT MEDICAL SYSTEMS, INC. | 5.5 F Worley Advanced LVI Lateral Vein Introducer | 08/27/2015 |
| K031922 | MERIT MEDICAL SYSTEMS, INC. | CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W | 10/01/2003 |
| K132720 | MERIT MEDICAL SYSTEMS, INC. | HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH | 02/12/2014 |
| K132164 | MERIT MEDICAL SYSTEMS, INC. | HEARTSPAN STEERABLE INTRODUCER KIT | 09/17/2013 |
| K170668 | Merit Medical Systems, Inc. | HeartSpan Steerable Sheath Introducer | 04/05/2017 |
| K990975 | MERIT MEDICAL SYSTEMS, INC. | IN-LINE HEMOSTASIS VALVE | 03/15/2000 |
| K140513 | MERIT MEDICAL SYSTEMS, INC. | MERIT SAFETY INTRODUCER NEEDLE | 07/09/2014 |
| K122190 | MERIT MEDICAL SYSTEMS, INC. | PRELUDE 7F SHORT SHEATH INTRODUCER | 08/17/2012 |
| K173750 | Merit Medical Systems, Inc. | Prelude IDeal Hydrophilic Sheath Introducer | 02/15/2018 |
| K172117 | Merit Medical Systems, Inc. | Prelude Pursuit Splittable Sheath Introducer | 09/11/2017 |
| K082063 | MERIT MEDICAL SYSTEMS, INC. | PRELUDE SHORT SHEATH INTRODUCER | 10/15/2008 |
| K152381 | MERIT MEDICAL SYSTEMS, INC. | Prelude SNAP Splittable Hydrophilic Sheath Introducer | 10/30/2015 |
| K143255 | MERIT MEDICAL SYSTEMS, INC. | Prelude SNAP Splittable Sheath Introducer | 04/09/2015 |
| K150257 | Merit Medical Systems, Inc. | PreludeEASE Hydrophilic Sheath Introducer | 06/19/2015 |
| K140543 | MERIT MEDICAL SYSTEMS, INC. | PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER | 10/16/2014 |
| K022003 | MICRO THERAPEUTICS, INC. | TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 | 09/13/2002 |
| K914046 | MICROVENA CORP. | THE BIG EASY Y-ADAPTER | 11/08/1991 |
| K070816 | MICRUS DESIGN TECHNOLOGY, INC. | PERIPHERAL GUIDING SHEATH | 09/19/2007 |
| K960200 | MSI, INC. | INTROSTAT LEAD INTRODUCER | 07/02/1996 |
| K020964 | NEICH MEDICAL(SHENZHEN)COMPANY, LTD. | NEICH NM ADVANCE CATHETER SHEATH INTRODUCER | 10/11/2002 |
| K960625 | NEOSTAR MEDICAL TECHNOLOGIES, INC. | SPREADABLE SHEATH INTRODUCER SET | 08/08/1996 |
| K102925 | NEXGEN MEDICAL SYSTEMS, INC. | NEXGEN EXPANDABLE CATHETER | 11/10/2011 |
| K034025 | NMT MEDICAL, INC. | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC | 03/26/2004 |
| K960310 | NORTH AMERICAN INSTRUMENT CORP. | EPIC INTRODUCER SHEATH | 02/07/1996 |
| K915078 | NORTH AMERICAN INSTRUMENT CORP. | MORSE HEMOSTATIC CATHETER INTRODUCER SET | 06/10/1992 |
| K912961 | NORTH AMERICAN INSTRUMENT CORP. | MORSE VASCULAR INTRODUCER SET | 09/11/1991 |
| K830813 | NORTON PERFORMANCE PLASTICS CORP. | FRENCH PERCUTANEOUS SHEATH INTRODUCER | 04/28/1983 |
| K820710 | NORTON PERFORMANCE PLASTICS CORP. | NEONATAL INTRODUCER KIT | 04/01/1982 |
| K820581 | NORTON PERFORMANCE PLASTICS CORP. | NORTON JUGULAR KITS | 03/18/1982 |
| K800621 | NORTON PERFORMANCE PLASTICS CORP. | PERCUTANEOUS CATHETER INTRODUCER ADAPTER | 04/24/1980 |
| K800619 | NORTON PERFORMANCE PLASTICS CORP. | THERMODILUTION CATHETER INTRO. KIT | 04/24/1980 |
| K800620 | NORTON PERFORMANCE PLASTICS CORP. | VENOUS M/A INTERNAL JUGULAR KIT | 04/24/1980 |
| K854831 | NOVAMED PRODUCTS, INC. | VALVOKIT | 03/31/1986 |
| K942977 | NOVOSTE CORP. | NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE | 12/28/1995 |
| K900658 | NOVOSTE PUERTO RICO, INC. | INTRODUCER, PERCUTANEOUS | 08/23/1990 |
| K171206 | NuMED, Inc. | D'Vill Introducer | 10/20/2017 |
| K190974 | NuMED, Inc. | D'Vill Introducer | 05/14/2019 |
| K843719 | OCEAN MEDICAL PRODUCTS, LTD. | SINGLE WALL INTRODUCER NEEDLE | 10/18/1984 |
| K941428 | OHMEDA MEDICAL | EXACTA PERCUTANEOUS INTRODUCER SHEATH | 07/06/1994 |
| K910933 | OLYMPUS CORP. | OLYMPUS ANGIOSCOPY IRRIGATION SHEATH | 06/03/1991 |
| K873100 | OLYMPUS CORP. | OLYMPUS ANGIOSCOPY SHEATH | 02/29/1988 |
| K062852 | ONSET MEDICAL CORPORATION | BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 | 02/23/2007 |
| K092014 | ONSET MEDICAL CORPORATION | SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | 10/08/2009 |
| K152498 | ONSET MEDICAL CORPORATION | SoloPath Re-Collapsible Access System | 01/05/2016 |
| K121404 | ONSET MEDICAL CORPORATION | SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM | 05/03/2013 |
| K100819 | ONSET MEDICAL CORPORATION | THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | 08/02/2010 |
| K930194 | OPTICON MEDICAL, INC. | HEMOSTASIS VALVE AND TUBING SET | 09/22/1993 |
| K122958 | Oscor Inc. | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | 12/13/2012 |
| K101497 | Oscor Inc. | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | 10/20/2010 |
| K151951 | Oscor Inc. | Destino Reach | 09/22/2015 |
| K140406 | Oscor Inc. | DESTINO TWIST, STEERABLE GUIDING SHEATH | 04/17/2014 |
| K122084 | Oscor Inc. | INTRODUCER SET, MODEL ADELANTE-S SERIES | 08/29/2012 |
| K130633 | Oscor Inc. | INTRODUCER SETS, MODEL ADELANTE RADIAL | 02/13/2014 |
| K073100 | Oscor Inc. | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S | 11/30/2007 |
| K140917 | Oscor Inc. | INTRODUCER, MODEL ADELANTE MAGNUM | 07/09/2014 |
| K831751 | OSCOR INC. | LEAD INTRODUCER SETS-EB-S8 & EB-S12 | 10/20/1983 |
| K090114 | Oscor Inc. | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S | 06/04/2009 |
| K122960 | Oscor Inc. | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | 12/13/2012 |
| K120459 | Oscor Inc. | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | 06/29/2012 |
| K890277 | OSCOR MEDICAL CORP. | HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT | 03/10/1989 |
| K931662 | PACE MEDICAL | LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES | 08/31/1993 |
| K871208 | PACESETTER SYSTEMS | UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M | 06/05/1987 |
| K834074 | PACKAGING TECHNOLOGIES, INC. | PERCUTANEOUS SHEATH INTRODUCER TRAY | 03/19/1984 |
| K113196 | PAJUNK GMBH MEDIZINTECHNOLOGIE | VASCULAR SONO | 02/06/2012 |
| K844840 | PARKE-DAVIS CO. | DESERET INTRODUCER SET | 05/16/1985 |
| K181031 | Pressure Products Medical Device Manufacturing LLC | TSI Transseptal Introducer | 10/26/2018 |
| K854941 | PROFESSIONAL MEDICAL SERVICES | PMS PERCUTANEOUS PUNCTURE NEEDLE | 04/16/1986 |
| K022634 | PROMEX, INC. | CO-AXIAL INTRODUCER NEEDLE | 11/06/2002 |
| K864705 | QUINTON, INC. | MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH | 02/13/1987 |
| K864352 | QUINTON, INC. | MODIFIED PEEL-AWAY INTRODUCER SET LINE | 01/06/1987 |
| K873394 | QUINTON, INC. | OVAL PULL-APART SHEATH/DILATOR | 09/30/1987 |
| K844693 | QUINTON, INC. | PEEL-AWAY INTRODUCER SET | 03/06/1985 |
| K873727 | QUINTON, INC. | PULL-APART INTRODUCER (SHEATH) | 10/07/1987 |
| K190369 | RAM Medical Innovations, Inc. | M-Y Sheath | 04/17/2019 |
| K932370 | REMINGTON MEDICAL, INC. | REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET | 11/09/1993 |
| K051468 | REX MEDICAL | INNER-LOCK INTRODUCER SHEATH | 08/04/2005 |
| K022170 | REX MEDICAL | INNER-LOCK LOCKING INTRODUCER SHEATHS | 01/21/2003 |
| K032569 | REX MEDICAL | SHORT INTRODUCER SHEATH | 09/16/2003 |
| K042399 | REX MEDICAL LP | MODIFICATION TO SHORT INTRODUCER SHEATH | 12/17/2004 |
| K170373 | Rhythm Xience, Inc. (RXI) | Flextra Steerable Introducer | 02/27/2017 |
| K171081 | Rhythm Xience, Inc. (RXI) | Guider Catheter Introducer | 05/09/2017 |
| K983039 | SCHNEIDER/NAMIC | EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF | 05/07/1999 |
| K980504 | SCHNEIDER/NAMIC | EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET | 08/07/1998 |
| K180178 | Shanghai Kindly Medical Instruments Co., Ltd. | Introducer Set | 09/10/2018 |
| K821324 | SHERWOOD MEDICAL CO. | ARGYLE INTRAMEDICUT CATHETER KIT | 07/14/1982 |
| K112407 | SMITHS MEDICAL MD, INC. | SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS | 02/09/2012 |
| K152177 | SONOSTIK, LLC | SonoStik IV Guide Wire Introducer | 10/01/2015 |
| K812325 | SORENSEN RESEARCH | INTK-08 8 FRENCH INTRODUCER KIT W/SIDE | 09/21/1981 |
| K771042 | SORENSEN RESEARCH | INTRODUCER, CAT. #INT-05FR. | 07/13/1977 |
| K771041 | SORENSEN RESEARCH | INTRODUCER, CAT. #INT-06FR. | 07/13/1977 |
| K771040 | SORENSEN RESEARCH | INTRODUCER, CAT. #INT-07FR. | 06/29/1977 |
| K050023 | SPECIALIZED HEALTH PRODUCTS, INC. | SECURELOC; ADVANCINTRODUCER | 02/18/2005 |
| K082580 | SPECTRA MEDICAL DEVICES, INC. | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | 12/08/2008 |
| K881825 | SPECTRAMED, INC. | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH | 09/28/1988 |
| K160716 | St Jude Medical, Inc | The Nanostim Introducer Kit | 04/14/2016 |
| K161102 | ST JUDE MEDICAL, INC. | Nanostim Introducer Kit | 05/19/2016 |
| K101883 | ST. JUDE MEDICAL | 6F ENGAGE/ENGAGE TR INTRODUCER | 09/07/2010 |
| K070417 | ST. JUDE MEDICAL | ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 | 06/05/2007 |
| K083402 | ST. JUDE MEDICAL | AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 | 12/15/2008 |
| K103083 | ST. JUDE MEDICAL | AGILIS ES STEERABLE INTRODUCER | 04/08/2011 |
| K061363 | ST. JUDE MEDICAL | AGILIS NXT STEERABLE INTRODUCER | 07/12/2006 |
| K083083 | ST. JUDE MEDICAL | AGILIS NXT STEERABLE INTRODUCER | 11/06/2008 |
| K110450 | ST. JUDE MEDICAL | AGILIS NXT STEERABLE INTRODUCER | 05/10/2011 |
| K081645 | ST. JUDE MEDICAL | AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 | 12/09/2008 |
| K031906 | ST. JUDE MEDICAL | APEEL CS CATHETER DELIVERY SYSTEM | 07/18/2003 |
| K093130 | ST. JUDE MEDICAL | ENGAGE TR INTRODUCER | 11/04/2009 |
| K092575 | ST. JUDE MEDICAL | ENGAGE/ENGAGE TR | 10/08/2009 |
| K111092 | ST. JUDE MEDICAL | ENGAGE/ENGAGE TR INTRODUCERS | 06/09/2011 |
| K023447 | ST. JUDE MEDICAL | MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) | 10/31/2002 |
| K013029 | ST. JUDE MEDICAL | SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 | 10/09/2001 |
| K070166 | ST. JUDE MEDICAL | STRADA CAROTID GUIDING SHEATH | 04/06/2007 |
| K052644 | ST. JUDE MEDICAL | SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER | 12/05/2005 |
| K140327 | ST. JUDE MEDICAL | ULTIMUM EV HEMOSTASIS INTRODUCER | 03/11/2014 |
| K003729 | ST. JUDE MEDICAL | ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), | 01/03/2001 |
| K091137 | ST. JUDE MEDICAL | ULTIMUM/ENGAGE/ENGAGE TR | 04/22/2009 |
| K012922 | ST. JUDE MEDICAL | ULTRAFLEX EV HEMOSTASIS INTRODUCER | 09/25/2001 |
| K111943 | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | AGILLS PF DELIVERY SYSTEM | 09/29/2011 |
| K042623 | ST. JUDE MEDICAL, DAIG DIVISION, INC. | AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 | 01/27/2005 |
| K051096 | ST. JUDE MEDICAL, DAIG DIVISION, INC. | APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 | 05/17/2005 |
| K001367 | ST. JUDE MEDICAL, INC. | FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX | 05/31/2000 |
| K140793 | ST. JUDE MEDICAL, INC. | NANOSTIM INTRODUCER KIT | 12/17/2014 |
| K001346 | ST. JUDE MEDICAL, INC. | ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX | 05/24/2000 |
| K061015 | ST.JUDE MEDICAL | FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER | 08/03/2006 |
| K792171 | STANCO MEDICAL, INC. | COMPLETE TRAY CENTRAL VENOUS PRESSURE | 11/13/1979 |
| K792170 | STANCO MEDICAL, INC. | PERCUTANEOUS SHEATH (MULTI-CATH)SIDE | 11/13/1979 |
| K792172 | STANCO MEDICAL, INC. | PERCUTANEOUS SHEATH INTRO. KIT OR TRAY | 11/13/1979 |
| K792131 | STANCO MEDICAL, INC. | TEMPORARY TRANSVENOUS PACMKER. ELECTRODE | 11/13/1979 |
| K792130 | STANCO MEDICAL, INC. | TRANSVENOUS BALLOON CATH. INTRO. KIT | 11/13/1979 |
| K123334 | STRYKER SUSTAINABILITY SOLUTIONS, INC. | REPROCESSED STEERABLE INTRODUCER | 01/24/2013 |
| K190644 | Surmodics, Inc. | Guide Sheath | 04/18/2019 |
| K151936 | SYNAPTIC MEDICAL LIMITED | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle | 12/04/2015 |
| K925633 | TARGET THERAPEUTICS | BALT INTRODUCER | 06/25/1993 |
| K860958 | TARGET THERAPEUTICS | CATHETER INTRODUCER | 04/23/1986 |
| K926340 | TELECTRONICS PACING SYSTEMS, INC. | NEW LEAD INTRODUCER KITS, VARIOUS MODELS | 05/27/1993 |
| K852918 | TELECTRONICS, INC. | SLIM ART J. BIP PACING LEAD USING POLY #030-2821 | 07/29/1985 |
| K852917 | TELECTRONICS, INC. | SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283 | 07/29/1985 |
| K852916 | TELECTRONICS, INC. | SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 | 07/29/1985 |
| K060519 | TELEFLEX MEDICAL | INTRODUCER ASSEMBLY WITH ROTATOR LOCK | 05/05/2006 |
| K920908 | TELEFLEX MEDICAL, INC. | OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1 | 10/06/1992 |
| K920907 | TELEFLEX MEDICAL, INC. | OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO | 10/06/1992 |
| K851141 | TELEFLEX MEDICAL, INC. | TELEFLEX MEDICAL INTRODUCER CATHETER | 05/16/1985 |
| K112554 | Teleflex Medical, Inc. | TRANSRADIAL ARTERY ACCESS DEVICES | 11/18/2011 |
| K861951 | TELEFLEX, INC. | MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER | 06/19/1986 |
| K860307 | TELEFLEX, INC. | PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET | 05/20/1986 |
| K123974 | TELEFLEX, INC. | PERCUTANEOUS INTRODUCER KIT | 02/21/2013 |
| K033681 | TERUMO CORP. | GLIDESHEATH | 12/11/2003 |
| K060666 | TERUMO MEDICAL CORP. | CAROTID ACCESS KIT | 06/29/2006 |
| K012812 | TERUMO MEDICAL CORP. | CAROTID GUIDING SHEATH | 11/14/2001 |
| K052185 | TERUMO MEDICAL CORP. | DESTINATION CAROTID GUIDING SHEATH | 09/06/2005 |
| K081045 | TERUMO MEDICAL CORP. | DESTINATION RENAL GUIDING SHEATH | 05/28/2008 |
| K080415 | TERUMO MEDICAL CORP. | DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | 03/07/2008 |
| K082644 | TERUMO MEDICAL CORP. | GLIDESHEATH | 09/18/2008 |
| K102008 | TERUMO MEDICAL CORP. | GLIDESHEATH | 07/21/2010 |
| K062858 | TERUMO MEDICAL CORP. | MODIFICATION TO GLIDESHEATH | 10/20/2006 |
| K062446 | TERUMO MEDICAL CORP. | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH | 10/23/2006 |
| K091329 | TERUMO MEDICAL CORP. | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | 05/29/2009 |
| K051601 | TERUMO MEDICAL CORP. | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | 08/04/2005 |
| K081046 | TERUMO MEDICAL CORP. | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | 05/21/2008 |
| K111606 | TERUMO MEDICAL CORP. | PINNACLE PRECISION ACCESS SYSTEM | 10/03/2011 |
| K003424 | TERUMO MEDICAL CORP. | PINNACLE R/O II OR RADIFOCUS INTRODUCER II | 11/21/2000 |
| K984260 | TERUMO MEDICAL CORP. | PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) | 01/26/1999 |
| K082847 | TERUMO MEDICAL CORP. | PINNACLE ROII INTRODUCER SHEATH | 10/29/2008 |
| K954234 | TERUMO MEDICAL CORP. | RADIFOCUS INTRODUCER II KIT | 11/27/1995 |
| K012854 | TERUMO MEDICAL CORP. | RENAL GUIDING SHEATH | 11/21/2001 |
| K863139 | TERUMO MEDICAL CORP. | TERUMO RADIFOCUS INTRODUCER KIT | 10/10/1986 |
| K172995 | Terumo Medical Corporation | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | 11/21/2017 |
| K152173 | TERUMO MEDICAL CORPORATION | Glidesheath | 12/01/2015 |
| K173831 | Terumo Medical Corporation | Glidesheath Slender | 05/08/2018 |
| K142183 | Terumo Medical Corporation | GLIDESHEATH SLENDER | 11/21/2014 |
| K122980 | Terumo Medical Corporation | GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ | 12/11/2012 |
| K181237 | Terumo Medical Corporation | Glidesheath Slender Tibial Pedal Kit | 08/03/2018 |
| K171491 | Terumo Medical Corporation | R2P Destination Slender Guiding Sheath | 10/05/2017 |
| K153771 | Texas Medical Technologies, Inc. | TXM Guiding Sheath | 09/13/2016 |
| K991647 | TFX MEDICAL GROUP | TFX MEDICAL INTRODUCER KIT | 01/04/2000 |
| K993191 | TFX MEDICAL, INC. | TFX MEDICAL INTRODUCER ASSEMBLY | 03/24/2000 |
| K855061 | THE KENDAL CO. | CURITY PERCUTANEOUS CATHETER INSERTION KIT | 04/16/1986 |
| K855060 | THE KENDAL CO. | CURITY PERCUTANEOUS CATHETER INSERTION TRAY | 04/16/1986 |
| K004026 | THOMAS MEDICAL PRODUCTS, INC. | BRAIDED GUIDING INTRODUCER | 07/09/2001 |
| K120158 | THOMAS MEDICAL PRODUCTS, INC. | CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS | 08/14/2012 |
| K083269 | THOMAS MEDICAL PRODUCTS, INC. | CROSSOVER | 02/03/2009 |
| K122431 | THOMAS MEDICAL PRODUCTS, INC. | HEARTSPAN STEERABLE INTRODUCER KIT | 01/29/2013 |
| K961780 | THOMAS MEDICAL PRODUCTS, INC. | HEMODIALYSIS INTRODUCER SET | 12/24/1996 |
| K043438 | THOMAS MEDICAL PRODUCTS, INC. | LARGE BORE SPLITTABLE INTRODUCER KIT | 02/15/2005 |
| K924456 | THOMAS MEDICAL PRODUCTS, INC. | LONG LENGTH PERCUTANEOUS INTRODUCER SET | 03/22/1993 |
| K013202 | THOMAS MEDICAL PRODUCTS, INC. | MODIFICATION TO BRAIDED GUIDING INTRODUCER | 10/23/2001 |
| K040713 | THOMAS MEDICAL PRODUCTS, INC. | MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM | 06/01/2004 |
| K020090 | THOMAS MEDICAL PRODUCTS, INC. | MODIFICATION TO TRANSSEPTAL INTRODUCER SET | 02/11/2002 |
| K931587 | THOMAS MEDICAL PRODUCTS, INC. | MULTI-PORT "Y" INTRODUCER SET | 10/06/1993 |
| K961466 | THOMAS MEDICAL PRODUCTS, INC. | PERCUTANEOUS INTRODUCER SET | 09/12/1996 |
| K902275 | THOMAS MEDICAL PRODUCTS, INC. | PERCUTANEOUS INTRODUCER SET | 09/26/1990 |
| K081341 | THOMAS MEDICAL PRODUCTS, INC. | REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) | 05/14/2008 |
| K003731 | THOMAS MEDICAL PRODUCTS, INC. | SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE | 04/10/2001 |
| K004025 | THOMAS MEDICAL PRODUCTS, INC. | SPLITTABLE SHEATH INTRODUCER KIT | 07/19/2001 |
| K934901 | THOMAS MEDICAL PRODUCTS, INC. | TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE | 01/21/1994 |
| K001926 | THORATEC LABORATORIES CORP. | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES | 09/22/2000 |
| K870542 | TITAN MEDICAL, INC. | VASCATH VASCULAR CATHETER PLACEMENT KIT | 04/27/1987 |
| K121504 | TOGO MEDIKIT CO., LTD. | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS | 09/27/2012 |
| K060190 | TOGO MEDIKIT CO., LTD. | SUPER SHEATH XL INTRODUCER SHEATH | 04/04/2006 |
| K152194 | TRANSAORTIC MEDICAL, INC. | transGlide Expandable Introducer | 04/07/2016 |
| K181817 | TransAortic Medical, Inc. | transGlideXT Expandable Introducer | 03/26/2019 |
| K181088 | Transseptal Solutions Ltd. | TSP Crosser Transseptal Access System | 09/28/2018 |
| K812964 | TRIAD MEDICAL DIVISION | INTRODUCER, PERCUTANEOUS SELDINGER | 11/16/1981 |
| K822247 | UNIVERSAL MEDICAL INSTRUMENT CORP. | "CATH-SEAL | 08/19/1982 |
| K962180 | UNIVERSAL MEDICAL INSTRUMENT CORP. | CATH SEAL | 11/07/1996 |
| K935077 | UNIVERSAL MEDICAL INSTRUMENT CORP. | CATH-SEAL | 06/07/1994 |
| K842259 | UNIVERSAL MEDICAL INSTRUMENT CORP. | PCI W/CATH-SEAL SIDE FLOW FITTING | 08/01/1984 |
| K850820 | UNIVERSAL MEDICAL INSTRUMENT CORP. | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID | 04/10/1985 |
| K861984 | UNIVERSAL MEDICAL INSTRUMENT CORP. | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO | 08/05/1986 |
| K112887 | UPSTREAM PERIPHERAL TECHNOLOGIES | UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR | 03/21/2012 |
| K942191 | URESIL CORP. | URESIL DILATOR | 09/21/1994 |
| K771982 | USCI, DIV. C.R. BARD, INC. | 888 ARTERIAL/VENOUS CATHETER INTRODUCER | 11/02/1977 |
| K770561 | USCI, DIV. C.R. BARD, INC. | CATHETER,PERCUTANEOUS INTRODUC. & SHEATH | 04/26/1977 |
| K940092 | USCI, DIV. C.R. BARD, INC. | USCI INPUT INTRODUCER SET | 08/10/1995 |
| K132789 | VASCULAR SOLUTIONS, INC. | FLIP INTRODUCER ACCESS KIT | 04/17/2014 |
| K180913 | Vascular Solutions, Inc. | VSI Micro-Introducer Kit | 05/09/2018 |
| K101604 | VASCULAR SOLUTIONS, INC. | VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V | 01/24/2011 |
| K043084 | VELOCIMED INC. | PREMERE DELIVERY SHEATH, MODEL PDS | 05/02/2005 |
| K030734 | VERTELINK CORPORATION | PATHWAY ACCESS SHEATH CATHETER | 09/10/2003 |
| K822593 | VERTEX MEDICAL CORP. | PERCUTANEOUS CATHETER INTRODUCER SET | 09/28/1982 |
| K051248 | VYGON CORP. | VYGON MICRO-ACCESS SAFETY INTRODUCER KIT | 10/27/2005 |
| K010913 | VYGON CORP. | VYGON SPLIT CANNULA INTRODUCER | 09/28/2001 |
| K120428 | W. L. GORE & ASSOCIATES, INC. | GORE DRYSEAL SHEATH | 04/20/2012 |
| K082356 | W. L. GORE & ASSOCIATES, INC. | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | 08/28/2008 |
| K032073 | W. L. GORE & ASSOCIATES, INC. | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | 08/13/2003 |
| K121234 | W. L. GORE & ASSOCIATES, INC. | GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING | 11/20/2012 |
| K160254 | W.L. GORE & ASSOCIATES, INC. | GORE DrySeal Flex Introducer Sheath | 05/12/2016 |
| K093791 | W.L. GORE & ASSOCIATES,INC | GORE DRYSEAL SHEATH | 03/22/2010 |
| K920998 | W.L. GORE & ASSOCIATES,INC | GORE TUNNELER, MODIFICATION | 06/03/1992 |
| K812143 | WILLSON | INTRODUCER, PERCUTANEOUS | 08/18/1981 |
| K844593 | XANMED CORP. | CARDIOVASCULAR CUSTOM SURGICAL KIT | 06/21/1985 |
| K843641 | XANMED CORP. | CATHETER INTRODUCER SYSTEM | 10/23/1984 |
| K843642 | XANMED CORP. | SUBCLAVIAN LEAD INTRODUCER SYS | 10/23/1984 |
| K000313 | XENTEK MEDICAL, INC. | TEARAWAY INTRODUCER SHEATH | 06/16/2000 |
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