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 |
| K140871 | ARSTASIS, INC. | AXERA 2 ACCESS SYSTEM | 06/06/2014 |
| K132263 | ARSTASIS, INC. | AXERA 2 ACCESS SYSTEM | 08/19/2013 |
| K123618 | ARSTASIS, INC. | AXERA 2 ACCESS SYSTEM | 03/24/2013 |
| 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 |
| K964814 | BIPORE, INC. | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | 05/07/1997 |
| K073434 | BIPORE, INC. | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | 04/01/2008 |
| K051513 | BIPORE, INC. | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | 12/07/2005 |
| 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 |
| K971608 | CORDIS CORP. | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | 07/21/1997 |
| 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 |
| 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 |
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