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 |
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 |
K132263 |
ARSTASIS, INC. |
AXERA 2 ACCESS SYSTEM |
08/19/2013 |
K140871 |
ARSTASIS, INC. |
AXERA 2 ACCESS SYSTEM |
06/06/2014 |
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 |
K121521 |
ARSTASIS, INC. |
AXERA ACCESS SYSTEM |
06/21/2012 |
K113110 |
ARSTASIS, INC. |
AXERA ACCESS SYSTEM |
11/09/2011 |
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 |
K051513 |
BIPORE, INC. |
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER |
12/07/2005 |
K073434 |
BIPORE, INC. |
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER |
04/01/2008 |
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 |
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 |
K984500 |
CORDIS CORP. |
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
12/23/1998 |
K974448 |
CORDIS CORP. |
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
02/06/1998 |
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 |
K014052 |
EDWARDS LIFESCIENCES, LLC. |
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL |
03/08/2002 |
K030944 |
EDWARDS LIFESCIENCES, LLC. |
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL |
06/20/2003 |
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 |
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 |
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EpieP, Inc. |
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10/29/2014 |
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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 |
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 |
K160721 |
KALILA MEDICAL, INC. |
Vado Steerable Sheath |
03/07/2017 |
K140420 |
KALILA MEDICAL, INC. |
VADO STEERABLE SHEATH |
04/01/2014 |
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 |
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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 |
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MERIT MEDICAL SYSTEMS, INC. |
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Merit Medical Systems, Inc. |
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Prelude Pursuit Splittable Sheath Introducer |
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MERIT MEDICAL SYSTEMS, INC. |
PRELUDE SHORT SHEATH INTRODUCER |
10/15/2008 |
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MERIT MEDICAL SYSTEMS, INC. |
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10/30/2015 |
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MERIT MEDICAL SYSTEMS, INC. |
Prelude SNAP Splittable Sheath Introducer |
04/09/2015 |
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Merit Medical Systems, Inc. |
PreludeEASE Hydrophilic Sheath Introducer |
06/19/2015 |
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MERIT MEDICAL SYSTEMS, INC. |
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER |
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MICRO THERAPEUTICS, INC. |
TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 |
09/13/2002 |
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MICROVENA CORP. |
THE BIG EASY Y-ADAPTER |
11/08/1991 |
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MICRUS DESIGN TECHNOLOGY, INC. |
PERIPHERAL GUIDING SHEATH |
09/19/2007 |
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MSI, INC. |
INTROSTAT LEAD INTRODUCER |
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NEICH MEDICAL(SHENZHEN)COMPANY, LTD. |
NEICH NM ADVANCE CATHETER SHEATH INTRODUCER |
10/11/2002 |
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NEOSTAR MEDICAL TECHNOLOGIES, INC. |
SPREADABLE SHEATH INTRODUCER SET |
08/08/1996 |
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NEXGEN MEDICAL SYSTEMS, INC. |
NEXGEN EXPANDABLE CATHETER |
11/10/2011 |
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NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC |
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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 |
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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 |
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NOVAMED PRODUCTS, INC. |
VALVOKIT |
03/31/1986 |
K942977 |
NOVOSTE CORP. |
NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE |
12/28/1995 |
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INTRODUCER, PERCUTANEOUS |
08/23/1990 |
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NuMED, Inc. |
D'Vill Introducer |
10/20/2017 |
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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 |
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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 |
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ONSET MEDICAL CORPORATION |
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER |
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OPTICON MEDICAL, INC. |
HEMOSTASIS VALVE AND TUBING SET |
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Oscor Inc. |
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY |
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10/20/2010 |
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Oscor Inc. |
Destino Reach |
09/22/2015 |
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Oscor Inc. |
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04/17/2014 |
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Oscor Inc. |
INTRODUCER SET, MODEL ADELANTE-S SERIES |
08/29/2012 |
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Oscor Inc. |
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02/13/2014 |
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Oscor Inc. |
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11/30/2007 |
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INTRODUCER, MODEL ADELANTE MAGNUM |
07/09/2014 |
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OSCOR INC. |
LEAD INTRODUCER SETS-EB-S8 & EB-S12 |
10/20/1983 |
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Oscor Inc. |
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06/04/2009 |
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STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO |
12/13/2012 |
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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 |
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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 |
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PROMEX, INC. |
CO-AXIAL INTRODUCER NEEDLE |
11/06/2002 |
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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 |
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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 |
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SPECIALIZED HEALTH PRODUCTS, INC. |
SECURELOC; ADVANCINTRODUCER |
02/18/2005 |
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SPECTRA MEDICAL DEVICES, INC. |
SPECTRA GUIDEWIRE INTRODUCER NEEDLE |
12/08/2008 |
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SPECTRAMED, INC. |
MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH |
09/28/1988 |
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St Jude Medical, Inc |
The Nanostim Introducer Kit |
04/14/2016 |
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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 |
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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 |
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STANCO MEDICAL, INC. |
COMPLETE TRAY CENTRAL VENOUS PRESSURE |
11/13/1979 |
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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 |
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 |
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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. |
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07/29/1985 |
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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 |
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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 |
K081046 |
TERUMO MEDICAL CORP. |
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
05/21/2008 |
K091329 |
TERUMO MEDICAL CORP. |
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
05/29/2009 |
K051601 |
TERUMO MEDICAL CORP. |
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
08/04/2005 |
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 |
K142183 |
Terumo Medical Corporation |
GLIDESHEATH SLENDER |
11/21/2014 |
K173831 |
Terumo Medical Corporation |
Glidesheath Slender |
05/08/2018 |
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 |
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THOMAS MEDICAL PRODUCTS, INC. |
PERCUTANEOUS INTRODUCER SET |
09/26/1990 |
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THOMAS MEDICAL PRODUCTS, INC. |
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05/14/2008 |
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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 |
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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. |
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TOGO MEDIKIT CO., LTD. |
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UNIVERSAL MEDICAL INSTRUMENT CORP. |
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UNIVERSAL MEDICAL INSTRUMENT CORP. |
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11/07/1996 |
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UNIVERSAL MEDICAL INSTRUMENT CORP. |
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06/07/1994 |
K842259 |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
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08/01/1984 |
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UNIVERSAL MEDICAL INSTRUMENT CORP. |
PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID |
04/10/1985 |
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UNIVERSAL MEDICAL INSTRUMENT CORP. |
UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO |
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URESIL CORP. |
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VERTELINK CORPORATION |
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09/10/2003 |
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VERTEX MEDICAL CORP. |
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VYGON CORP. |
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VYGON CORP. |
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W. L. GORE & ASSOCIATES, INC. |
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W. L. GORE & ASSOCIATES, INC. |
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W. L. GORE & ASSOCIATES, INC. |
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W.L. GORE & ASSOCIATES,INC |
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XANMED CORP. |
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XANMED CORP. |
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