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
K131300 ACCESS SCIENTIFIC, LLC THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER 06/07/2013
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
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
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
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
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
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
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
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
K974448 CORDIS CORP. CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM 02/06/1998
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
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
K014052 EDWARDS LIFESCIENCES, LLC. EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL 03/08/2002
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