FDA 510(k) Applications for Medical Device Product Code "DQY"
(Catheter, Percutaneous)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K121352 | Abbott Vascular | ARMADA 14XXT PTA CATHETER | 08/15/2012 |
| K014118 | ABBOTT VASCULAR INC. | MODIFICATION TO SUPERCROSS CATHETER | 01/11/2002 |
| K001856 | ABBOTT VASCULAR INC. | SUPERCROSS CATHETER | 03/07/2001 |
| K090509 | ABBOTT VASCULAR-VASCULAR SOLUTIONS | FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER | 03/20/2009 |
| K831636 | ACCU-LINE | PERCUTANEOUS INTRODUCER KIT | 08/24/1983 |
| K171176 | Acrostak (Schweiz) AG | M-CATH Microcatheter | 09/15/2017 |
| K062084 | ACUMEN MEDICAL, INC. | 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 | 08/18/2006 |
| K070051 | ACUMEN MEDICAL, INC. | ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM | 04/06/2007 |
| K042381 | ACUMEN MEDICAL, INC. | CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 | 12/28/2004 |
| K871425 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER | 05/22/1987 |
| K926421 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH | 03/23/1993 |
| K874874 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP | 02/18/1988 |
| K952205 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS POWERBASE GUILDING CATHETER | 08/04/1995 |
| K940559 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS POWERBASE(TM) CORONARY GUIDING CATHETER | 05/03/1994 |
| K934009 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS POWERGUIDE CORONARY GUIDING CATHETER | 01/11/1994 |
| K885237 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS SELECTIVE INFUSION CATHETER | 03/16/1989 |
| K883564 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES | 11/03/1988 |
| K875269 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE | 02/12/1988 |
| K953987 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS TOURGIDE GUIDING CATHETER | 12/07/1995 |
| K904884 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ACS URETHAN CORONARY GUIDING CATHETER | 01/03/1991 |
| K831563 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | CORONARY GUIDING CATHETER-MODIFIED | 06/30/1983 |
| K831717 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | CORONARY INFUSION CATHETER | 06/30/1983 |
| K850353 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | CORONARY INFUSION CATHETER W/SIDEHOLES | 04/10/1985 |
| K882803 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST | 09/16/1988 |
| K822393 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | INTRAOPERATIVE BALLOON DILATION CATH. | 11/01/1982 |
| K821189 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | MULTIPURPOSE CATHETER | 07/08/1982 |
| K833801 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | RIGHT CORONARY GUIDING CATHETER | 03/12/1984 |
| K994229 | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | VERIPATH PERIPHERAL GUIDING CATHETER | 02/25/2000 |
| K153488 | Advanced Catheter Therapies, Inc. | Occlusion Perfusion Catheter | 02/25/2016 |
| K151554 | ADVANCED CATHETER THERAPIES, INC. | Occlusion Perfusion Catheter | 09/15/2015 |
| K130525 | ADVANCED CATHETER THERAPIES, INC. | OCCLUSION PERFUSION CATHETER | 10/03/2013 |
| K070238 | AGA MEDICAL CORP. | AMPLATZER RELIANT CATHETER DELIVERY SYSTEM | 02/28/2007 |
| K093476 | AGA MEDICAL CORP. | AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 | 02/05/2010 |
| K083214 | AGA MEDICAL CORP. | AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 | 05/12/2009 |
| K091793 | AGA MEDICAL CORP. | AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 | 07/09/2009 |
| K072313 | AGA MEDICAL CORP. | AMPLATZER TORQVUE DELIVERY SYSTEM | 11/02/2007 |
| K080994 | AGA MEDICAL CORP. | AMPLATZER TORQVUE EXCHANGE SYSTEM | 05/16/2008 |
| K080757 | AGA MEDICAL CORP. | AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM | 04/18/2008 |
| K120120 | AGA MEDICAL CORPORATION | AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH | 03/15/2012 |
| K121611 | AGA MEDICAL CORPORATION | AMPLATZER TORQVUE FX | 08/23/2012 |
| K163000 | AGA Medical Corporation (Wholly Owned by St. Jude Medical Co | AMPLATZER TorqVue 45x45 Delivery Sheath | 12/23/2016 |
| K162228 | AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR | TorqVue Low Profile Delivery Catheter | 09/09/2016 |
| K920331 | AKCESS MEDICAL PRODUCTS, INC. | RIGHT ATRIAL CATHETER KITS | 04/22/1992 |
| K911333 | AKCESS MEDICAL PRODUCTS, INC. | RIGHT ATRIAL CATHETERS | 09/23/1991 |
| K820516 | ALIMED, INC. | ARTERIAL CANALIZATION DEVICE | 04/15/1982 |
| K141529 | ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S | ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER | 12/03/2014 |
| K873485 | AMERICAN EDWARDS LABORATORIES | EDSLAB (R) OCCLUSION BALLOON CATHETER | 12/03/1987 |
| K813514 | AMERICAN EDWARDS LABORATORIES | EDSLAB CATHETER COVER | 12/29/1981 |
| K862724 | AMERICAN EDWARDS LABORATORIES | VEIN VALVE CUTTER | 01/02/1987 |
| K911747 | AMERICAN INTERVENTIONAL TECHNOLOGY | PRO-GUIDE | 09/18/1991 |
| K852491 | AMERICAN PHARMASEAL DIV. AHSC | AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER | 09/25/1985 |
| K831807 | AMERICAN PHARMASEAL DIV. AHSC | CATHETER INSERTION TRAYS, VARIOUS #'S | 07/18/1983 |
| K831729 | AMERICAN PHARMASEAL DIV. AHSC | PERCUTANEOUS CATHETER INSERTION TRAY | 07/18/1983 |
| K861165 | AMERICAN PHARMASEAL DIV. AHSC | PHARMASEAL DUAL LUMEN CATHETER | 05/05/1986 |
| K853714 | AMERICAN PHARMASEAL DIV. AHSC | PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA | 01/13/1986 |
| K051060 | ANGIODYNAMICS, INC. | ANGIODYNAMICS PROFILER PTA BALLOON CATHETER | 05/26/2005 |
| K062609 | ANGIODYNAMICS, INC. | MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER | 10/06/2006 |
| K032069 | ANGIODYNAMICS, INC. | WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER | 08/27/2003 |
| K111750 | ANGIOSLIDE, LTD | EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE | 07/21/2011 |
| K902256 | APPLIED VASCULAR DEVICES, INC. | IRRIGATION CATHETER 4, 6 AND 10 FRENCH | 02/15/1991 |
| K833303 | ARGON MEDICAL CORP. | DUOFLO 6F | 12/27/1983 |
| K171146 | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | 06/23/2017 |
| K854137 | ARROW INTL., INC. | ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC | 12/03/1985 |
| K820009 | ARROW INTL., INC. | ARROW JUGULAR PUNCTURE KIT 16 GA. | 01/22/1982 |
| K820648 | ARROW INTL., INC. | ARROW M.I.S. MULTI-LUMEN CATHETERIZA | 04/14/1982 |
| K093050 | ARROW INTL., INC. | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | 12/18/2009 |
| K810962 | ARROW INTL., INC. | ARROW VESSEL CATHETER. KIT W/20GA INDWEL | 04/29/1981 |
| K843263 | ARROW INTL., INC. | ARROW-JOHANS ECG ADAPTOR | 09/20/1984 |
| K933033 | ARROW INTL., INC. | GUIDING CATHETER HEMOSTASIS VALVE CAP | 09/10/1993 |
| K904404 | ARROW INTL., INC. | MULTI-LUMEN CENTRAL VENOUS CATHETER SET | 02/15/1991 |
| K021120 | ARROW INTL., INC. | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP | 05/02/2002 |
| K840336 | ARROW INTL., INC. | RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI | 02/17/1984 |
| K862056 | ARROW INTL., INC. | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP | 08/25/1986 |
| K984482 | ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC. | AVE GL-1 GUIDING CATHETER | 07/30/1999 |
| K152447 | ASAHI INTECC CO., LTD. | ASAHI Caravel | 01/22/2016 |
| K161362 | Asahi Intecc Co., Ltd. | ASAHI Corsair Armet | 06/14/2016 |
| K152249 | ASAHI INTECC CO., LTD. | ASAHI Corsair Armet | 03/04/2016 |
| K151103 | ASAHI INTECC CO., LTD. | ASAHI Corsair Microcatheter | 06/23/2015 |
| K083127 | ASAHI INTECC CO., LTD. | ASAHI CORSAIR MICROCATHETER | 02/03/2009 |
| K161126 | ASAHI INTECC CO., LTD. | ASAHI Corsair Pro | 08/25/2016 |
| K141981 | ASAHI INTECC CO., LTD. | ASAHI FUBUKI 043 / ASAHI FUBUKI | 03/09/2015 |
| K061601 | ASAHI INTECC CO., LTD. | ASAHI PRECIOUS GUIDE CATHETER | 11/17/2006 |
| K051772 | ASAHI INTECC CO., LTD. | ASAHI TORNUS SUPPORT CATHETER | 09/26/2005 |
| K060745 | ASAHI INTECC CO., LTD. | ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY | 06/23/2006 |
| K091188 | ASAHI INTECC CO., LTD. | ASAHI ZENYTEEX GUIDING CATHETER | 02/26/2010 |
| K072316 | ASAHI INTECC CO., LTD. | PRECIOUS PLUS GUIDE CATHETER | 09/17/2007 |
| K132556 | ASAHI INTECC CO., LTD. | SHEATHLESS EAUCATH CORONARY GUIDE CATHETER | 10/24/2013 |
| K062885 | ASAHI INTECC CO., LTD. | STRIDE MICROCATHETER | 06/13/2007 |
| K161546 | ASHITAKA FACTORY OF TERUMO CORPORATION | R2P SlenGuide | 10/14/2016 |
| K061680 | ATRIUM MEDICAL CORP. | ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER | 12/15/2006 |
| K093431 | ATRIUM MEDICAL CORP. | CLEARWAY OTW MODEL 85912 | 04/20/2010 |
| K113112 | ATRIUM MEDICAL CORP. | CLEARWAY RX NB CATHETER | 11/17/2011 |
| K111704 | AVINGER, INC. | AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX | 09/09/2011 |
| K112579 | AVINGER, INC. | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER | 10/06/2011 |
| K101647 | AVINGER, INC. | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 | 08/06/2010 |
| K102022 | AVINGER, INC. | WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S | 08/06/2010 |
| K083313 | AVINGER, INC. | WILDCAT 7F GUIDEWIRE SUPPORT CATHETER | 02/02/2009 |
| K842084 | AXIOM MEDICAL, INC. | AXIOM FEMORAL VENUS CATHETER | 08/01/1984 |
| K973371 | B. BRAUN MEDICAL, INC. | CERTODYN RAECG UNIVERSAL ADAPTER | 11/24/1997 |
| K052236 | BARD PERIPHERAL VASCULAR, INC. | BARD ATLAS PTA BALLOON DILATATION CATHETER | 08/23/2005 |
| K072283 | BARD PERIPHERAL VASCULAR, INC. | DORADO PTA BALLOON DILATATION CATHETER | 09/19/2007 |
| K103367 | BARD PERIPHERAL VASCULAR, INC. | SEEKER CROSSING SUPPORT CATHETER | 12/08/2010 |
| K161986 | BARD PERIPHERAL VASCULAR, INC. | SIDEKICK and USHER Support Catheters | 08/04/2016 |
| K883174 | BAXTER HEALTHCARE CORP. | MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE | 10/14/1988 |
| K101117 | BAYLIS MEDICAL CO., INC. | LEV-OR DILATION CATHETER OTW | 07/16/2010 |
| K855201 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | BARD PARKER PERFUSION CATHETER | 04/29/1986 |
| K852099 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | BARD-PARKER IRRIGATION CATHETER | 08/09/1985 |
| K870075 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | CENTRAL VENOUS CATHETER | 04/27/1987 |
| K884129 | BIO MEDICUS, INC. | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET | 12/21/1988 |
| K042553 | BIOCARDIA, INC. | BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER | 02/17/2005 |
| K962717 | BIOCOMPATIBLES CARDIOVASCULAR, INC. | 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING | 02/12/1997 |
| K082933 | BIOTRONIK, INC. | PASSEO-35 PTA CATHETER | 11/03/2008 |
| K033217 | BIOTRONIK, INC. | PHERON PTA CATHETER | 10/31/2003 |
| K033320 | BIOTRONIK, INC. | SCOUT PRO | 11/19/2003 |
| K060807 | BIOTRONIK, INC. | SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM | 04/24/2006 |
| K093303 | BIOTRONIK, INC. | SCOUTPRO 7F LONG CATHETERS | 11/20/2009 |
| K072329 | BIOTRONIK, INC. | SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED | 03/25/2008 |
| K060655 | BIOTRONIK, INC. | SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H | 04/04/2006 |
| K101776 | BIOTRONIK, INC. | SCOUTPRO ACS | 07/23/2010 |
| K080988 | BIOTRONIK, INC. | SCOUTPRO CS LEAD INTRODUCER SYSTEM | 05/07/2008 |
| K101282 | BIOTRONIK, INC. | SCOUTPRO HEMOSTATIC VALVE | 07/21/2010 |
| K071665 | BIOTRONIK, INC. | SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 | 07/18/2007 |
| K123324 | BIOTRONIK, INC. | SELECTRA 7F CATHETERS | 01/11/2013 |
| K111839 | BIOTRONIK, INC. | SELECTRA ACCESSORY KIT | 09/26/2011 |
| K131978 | BIOTRONIK, INC. | SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL | 08/23/2013 |
| K151409 | BIOTRONIK, INC. | Selectra Catheters and Selectra Accessory Kit | 08/07/2015 |
| K110461 | BIOTRONIK, INC. | SELECTRA CS LEAD INTRODUCER SYSTEM | 04/20/2011 |
| K111154 | BIOTRONIK, INC. | SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 | 05/23/2011 |
| K112482 | BIOTRONIK, INC. | SELECTRA SLITTER TOOL | 09/26/2011 |
| K020028 | BOSTON SCIENTIFIC | 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX | 01/22/2002 |
| K132914 | BOSTON SCIENTIFIC | ACUITY PRO LEAD DELIVERY SYSTEM | 04/03/2014 |
| K123765 | BOSTON SCIENTIFIC | GUIDEZILLA GUIDE EXTENSION CATHETER | 03/19/2013 |
| K112303 | BOSTON SCIENTIFIC | RUBICON SUPPORT CATHETER | 11/09/2011 |
| K180864 | Boston Scientific | WATCHMAN TruSeal Access System | 07/20/2018 |
| K963663 | BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES | 11F GUIDING CATHETER | 01/13/1997 |
| K010874 | BOSTON SCIENTIFIC CORP. | 6F MACH 1, MODEL 34356-XXX | 06/21/2001 |
| K111252 | BOSTON SCIENTIFIC CORP. | ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F | 06/02/2011 |
| K033441 | BOSTON SCIENTIFIC CORP. | BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER | 11/21/2003 |
| K021721 | BOSTON SCIENTIFIC CORP. | EQUALIZER BALLOON CATHETER | 06/20/2002 |
| K042568 | BOSTON SCIENTIFIC CORP. | EXCELSIOR 1018 AND SL-10 MICROCATHETERS | 10/15/2004 |
| K930476 | BOSTON SCIENTIFIC CORP. | GUIDING CATHETER | 02/10/1994 |
| K062202 | BOSTON SCIENTIFIC CORP. | OCCLUSION BALLOON | 10/20/2006 |
| K122394 | BOSTON SCIENTIFIC CORP. | RUBICON 18 SUPPORT CATHETER | 08/30/2012 |
| K053118 | BOSTON SCIENTIFIC CORP. | STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX | 12/16/2005 |
| K053116 | BOSTON SCIENTIFIC CORP. | STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX | 12/16/2005 |
| K050599 | BOSTON SCIENTIFIC CORP. | TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER | 06/03/2005 |
| K011889 | BOSTON SCIENTIFIC CORP. | ULTRA -THIN SDS BALLOON DILATATION CATHETER | 12/21/2001 |
| K050389 | BOSTON SCIENTIFIC CORP. | ULTRA-SOFT SV BALLOON DILATATION CATHETER | 05/25/2005 |
| K171612 | Boston Scientific Corporation | ACUITY Pro Lead Delivery System | 06/30/2017 |
| K163314 | Boston Scientific Corporation | Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter | 03/23/2017 |
| K171452 | Boston Scientific Corporation | MAMBA and MAMBA FLEX Microcatheters | 08/21/2017 |
| K062594 | Boston Scientific Corporation | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM | 09/20/2006 |
| K060572 | Boston Scientific Corporation | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM | 03/15/2006 |
| K171913 | Boston Scientific Corporation | Rubicon 14, 18 and 35 Support Catheters | 07/25/2017 |
| K152401 | BOSTON SCIENTIFIC CORPORATION | Stingray LP Catheter | 12/04/2015 |
| K021735 | BOSTON SCIENTIFIC SCIMED, INC. | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER | 08/08/2002 |
| K980453 | BOSTON SCIENTIFIC SCIMED, INC. | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | 08/11/1998 |
| K981413 | BOSTON SCIENTIFIC SCIMED, INC. | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | 05/13/1998 |
| K935292 | BOSTON SCIENTIFIC SCIMED, INC. | SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER | 06/10/1994 |
| K943622 | BOSTON SCIENTIFIC SCIMED, INC. | SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER | 11/30/1994 |
| K013789 | BOSTON SCIENTIFIC, TARGET | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | 12/06/2001 |
| K010853 | BOSTON SCIENTIFIC, TARGET | GUIDER SOFTIP GUIDING CATHETER XF 5F | 04/18/2001 |
| K895753 | BREVET, INC. | BREVET DISPOSABLE CONNECTORS | 11/14/1989 |
| K102725 | BRIDGE MEDICAL, INC. | CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M | 05/10/2011 |
| K113589 | BRIDGEPOINT MEDICAL | BIGBOSS CATHETER | 01/04/2012 |
| K091841 | BRIDGEPOINT MEDICAL | BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 | 09/02/2009 |
| K081130 | BRIDGEPOINT MEDICAL | BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER | 05/14/2009 |
| K111963 | BRIDGEPOINT MEDICAL | BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER | 08/10/2011 |
| K080987 | BRIDGEPOINT MEDICAL | BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES | 02/06/2009 |
| K120129 | BRIDGEPOINT MEDICAL | MANTARAY CATHETER | 02/03/2012 |
| K101591 | BRIDGEPOINT MEDICAL | STINGRAY ORIENTING BALLOON CATHETER | 08/06/2010 |
| K810461 | BURRON MEDICAL PRODUCTS, INC. | BURRON CENTRAL VEIN CATHERIZATION KIT | 03/11/1981 |
| K810460 | BURRON MEDICAL PRODUCTS, INC. | BURRON PERCUTANEOUS INDUCER SET | 03/11/1981 |
| K040243 | C.R. BARD, INC. | BARD ATLAS PTA BALLOON DILATATION CATHETER | 02/13/2004 |
| K014212 | C.R. BARD, INC. | BARD CONQUEST PTA BALLOON DILATATION CATHETER | 01/17/2002 |
| K012913 | C.R. BARD, INC. | BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER | 09/28/2001 |
| K010169 | C.R. BARD, INC. | BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER | 02/13/2001 |
| K083657 | C.R. BARD, INC. | CONQUEST PTA BALLOON DILATATION CATHETER | 12/24/2008 |
| K905249 | C.R. BARD, INC. | NEW USCI 7F PTCA GUIDING CATHETER | 02/19/1991 |
| K131493 | C.R. BARD, INC. | SIDEKICK AND USHER SUPPORT CATHETERS | 08/02/2013 |
| K891069 | C.R. BARD, INC. | USCI CORONARY INFUSION CATHETER | 08/09/1989 |
| K890152 | C.R. BARD, INC. | USCI PROBING CATHETER | 08/17/1989 |
| K933019 | C.R. BARD, INC. | USCI SUPER 6 6F PTCA GUIDING CATHETER | 09/28/1993 |
| K894682 | C.R. BARD, INC. | USCI UNCOATED GUIDING CATHETERS | 09/12/1989 |
| K111850 | C.R. BARD, INC. | VACCESS PTA DILATATION CATHETER | 07/13/2011 |
| K950635 | CANDELA LASER CORP. | CANDEKA DUKATIR SETS | 03/01/1995 |
| K950634 | CANDELA LASER CORP. | CANDELA SHEATH SETS | 03/01/1995 |
| K093969 | CARDIAC PACEMAKERS, INC. | ACUITY BREAK-AWAY GUIDE CATHETER | 03/05/2010 |
| K080154 | CARDIAC PACEMAKERS, INC. | ACUITY UNIVERSAL CUTTER | 03/20/2008 |
| K973298 | CARDIMA, INC. | CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER | 06/26/1998 |
| K951603 | CARDIMA, INC. | CARDIMA, INC. FORERUNNER | 10/05/1995 |
| K974683 | CARDIMA, INC. | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER | 06/22/1999 |
| K833873 | CARDIO SEARCH, INC. | CARDIOSEARCH RIGHT ATRIAL CATH- | 06/11/1984 |
| K832064 | CARDIO SEARCH, INC. | VENOUS CATHETER | 08/08/1983 |
| K852791 | CARDIO-VASCULAR INNOVATIONS, INC. | 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS | 11/05/1985 |
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| K132652 | SEQUENT MEDICAL, INC | VIA MICROCATHETER, VIA PLUS MICROCATHETER | 12/20/2013 |
| K162565 | SEQUENT MEDICAL, INC. | VIA 17 Microcatheter | 02/18/2017 |
| K841797 | SHILEY, INC. | MULTIPRO CATHETER | 08/10/1984 |
| K143459 | SILK ROAD MEDICAL, INC | Silk Road Acccess Catheter | 04/01/2015 |
| K130649 | SILK ROAD MEDICAL, INC | SILK ROAD ACCESS CATHETER | 11/01/2013 |
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| K112032 | SPECTRANETICS CORP. | 8FR TURBO - TANDEM SYSTEM | 10/17/2011 |
| K090913 | SPECTRANETICS CORP. | CROSS-PILOT TURBO ELITE SUPPORT CATHETER | 05/04/2009 |
| K991059 | SPECTRANETICS CORP. | SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 | 11/16/1999 |
| K022138 | SPECTRANETICS CORP. | SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 | 09/23/2002 |
| K082559 | SPECTRANETICS CORP. | SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER | 12/11/2008 |
| K033678 | SPECTRANETICS CORP. | SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 | 02/23/2004 |
| K092396 | SPECTRANETICS CORP. | SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS | 09/04/2009 |
| K082561 | SPECTRANETICS CORP. | SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS | 12/10/2008 |
| K072750 | SPECTRANETICS CORP. | SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 | 12/04/2007 |
| K091299 | SPECTRANETICS CORP. | SPECTRANETICS TURBO-TANDEM SYSTEM | 07/01/2009 |
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| K142235 | St. Jude Medical | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter | 12/18/2014 |
| K082932 | ST. JUDE MEDICAL | CPS AIM SL SLITTABLE INNER CATHETER | 12/12/2008 |
| K130252 | ST. JUDE MEDICAL | CPS AIM UNIVERSAL SLITTABLE INNER CATHETER | 03/20/2013 |
| K142239 | St. Jude Medical | CPS Direct MediGuide Enabled outer catheter | 12/18/2014 |
| K061710 | ST. JUDE MEDICAL | CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS | 07/14/2006 |
| K053277 | ST. JUDE MEDICAL | CPS DIRECT SL OUTER CATHETER | 02/24/2006 |
| K130257 | ST. JUDE MEDICAL | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER | 03/20/2013 |
| K063638 | ST. JUDE MEDICAL | MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 | 05/11/2007 |
| K061843 | ST. JUDE MEDICAL | VENTURE WIRE CONTROL CATHETER, MODEL WCC | 08/01/2006 |
| K090613 | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 | 07/01/2009 |
| K120296 | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER | 05/11/2012 |
| K103250 | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | CPS DIRECT SL II SLITTABLE OUTER CATHETER | 01/19/2011 |
| K092075 | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 | 08/07/2009 |
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| K131592 | ST. JUDE MEDICAL, INC. | ENLIGHTN RENAL GUIDE CATHETER | 01/31/2014 |
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| K021802 | STEREOTAXIS, INC. | STEREOTAXIS CATHETER ADVANCER SYSTEM | 04/08/2003 |
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| K163259 | STRYKER NEUROVASCULAR | AXS Offset Delivery Assist Catheter | 07/28/2017 |
| K142565 | Stryker Neurovascular | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter | 11/14/2014 |
| K113778 | STRYKER NEUROVASCULAR | EXCELSIOR XT-27 MICROCATHETER | 04/20/2012 |
| K132542 | STRYKER NEUROVASCULAR | TRANSGATE GUIDE CATHETER | 11/15/2013 |
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| K840761 | SURGIMED CORP. | SILVERTORQUE VISCERAL CATHETER | 06/11/1984 |
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| K935597 | TARGET THERAPEUTICS | FASGUIDE CATHETER | 10/18/1994 |
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| K854000 | TARGET THERAPEUTICS | INFUSION CATHETER W/SIDE HOLES | 11/05/1985 |
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| K170041 | XABLECATH, INC. | XableCath Support Catheter | 09/07/2017 |
| K180986 | XableCath, Inc. | XableCath Support Catheter Product Family | 05/15/2018 |
| K032660 | XTRAK MEDICAL INC. | XTRAK SUPPORT CATHETER | 10/29/2003 |
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