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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
WALLSTENT (TIPS, ILIAC, VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S011)Boston Scientific Scimed, Inc.2002-05-10
HIGHSAIL CORONARY DILATATION CATHETERS (P810046/S212)Advanced Cardiovascular Systems, Inc.2002-05-10
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (P930031/S013)Boston Scientific Corp2002-05-10
HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM (P900043/S031)Cordis Corp.2002-05-10
MEDTRONIC KAPPA 700 SERIES OF IPGS (P980035/S024)Medtronic, Inc.2002-05-07
BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM(RX)/BX VELOCITY STENT WITHHEPACOAT ON RAPTORRAIL STENT DELIVERY (P900043/S039)Cordis Corp.2002-05-03
AMPLATZER SEPTAL OCCLUDER (P000039/S002)ABBOTT MEDICAL2002-05-03
ATTAIN OTW MODEL 4193 (P010015/S003)Medtronic, Inc.2002-05-02
NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S019)Best Vascular, Inc.2002-05-02
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012)Boston Scientific Corp2002-05-02
SPECTRANETICS LASER SHEATH (P960042/S008)Spectranetics (Philips)2002-05-02
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S071)Boston Scientific Corp2002-05-02
ACS MULTI-LINK CORONARY STENT SYSTEM (P970020/S037)Abbott Vascular, Inc.2002-05-01
NIR STENT DELIVERY SYSTEMS (P980001/S039)Boston Scientific Corp2002-05-01
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S010)Vascular Solutions, Inc.2002-04-30
CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S023)Corcym S.r.l.2002-04-30
THE CLOSURE 6 FR., S 6 FR. AND II 6 FR. SUTURE MEDIATED CLOSURE SYSTEMS (P960043/S038)Abbott Vascular, Inc.2002-04-29
THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS (P970035/S028)Medtronic, Ireland2002-04-29
BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM (P900043/S030)Cordis Corp.2002-04-29
ANCURE/AORTOILIAC ENDOGRAFT SYSTEM (P990017/S030)Boston Scientific Corp2002-04-24
BELOS VR-T ICD (P980023/S008)Biotronik, Inc.2002-04-24
S7 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM (P970035/S033)Medtronic, Ireland2002-04-24
MAVERICK MONORAIL/OVER THE WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PICA) CATHETERS (P860019/S181)Scimed Life Systems, Inc.2002-04-24
ANEURX STENT GRAFT SYSTEM (P990020/S008)Medtronic Vascular2002-04-23
MEDTRONIC HALL AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0 (P790018/S041)Medtronic Cardiac Surgery2002-04-23
STORMER OVER THE WIRE BALLOON DILATATION CATHETER (P790017/S076)Medtronic, Ireland2002-04-19
CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S001)Nmt Medical, Inc.2002-04-19
CARDIOSEAL (P000049/S002)Nmt Medical, Inc.2002-04-19
GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S002)Guidant Corp.2002-04-19
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S018)Thoratec Laboratories Corp.2002-04-18
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S015)Boston Scientific Corp2002-04-18
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S019)Thoratec Laboratories Corp.2002-04-18
GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S007)Guidant Corp.2002-04-17
HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510 (P980043/S001)Medtronic, Inc.2002-04-16
MODEL 2490A CARELINK MONITOR AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE MODEL 2491 VERSION 1.0 (P980016/S028)Medtronic Cardiac Rhythm Disease Management2002-04-16
GEM MODEL 7227 ICD (P900061/S056)Medtronic Cardiac Rhythm Disease Management2002-04-16
RAPTORRAIL PTCA DILATATION CATHETER (P880003/S084)Cordis Corp.2002-04-16
SCIMED MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM (P980009/S011)Boston Scientific Scimed, Inc.2002-04-12
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S070)Boston Scientific Corp2002-04-11
S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S035)Medtronic, Ireland2002-04-11
MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT (P790018/S043)Medtronic Cardiac Surgery2002-04-09
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S069)Boston Scientific Corp2002-04-04
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S009)Vascular Solutions, Inc.2002-04-03
INTRA COIL SELF-EXPANDING PERIPHERAL STENT (P000033)Medtronic Vascular, Inc.2002-04-03
PHILOS DR-T PULSE GENERATOR (P950037/S023)Biotronik, Inc.2002-04-02
MARQUIS DR ICD (P980016/S026)Medtronic Cardiac Rhythm Disease Management2002-03-28
THE AMPLATZER SEPTAL OCCLUDER DEVICE (P000039/S001)ABBOTT MEDICAL2002-03-27
TENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS (P960013/S010)ABBOTT MEDICAL2002-03-27
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S002)Edwards Lifesciences, LLC2002-03-26
QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM (P010049)Sub-Q, Inc.2002-03-25
NOVOSTE 60 MM BETA-CATH 5 FR SYSTEM (P000018/S018)Best Vascular, Inc.2002-03-25
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S033)Terumo Medical Corporation2002-03-20
LIFEVEST (P010030/S002)Zoll Manufacturing Corporation2002-03-20
MEDTRONIC KAPPA 700 SERIES PULSE GENERATOR PRODUCT FAMILY (P980035/S021)Medtronic, Inc.2002-03-18
MEDTRONIC KAPPA 700/600/800/900 PULSE GENERATORS (P980035/S023)Medtronic, Inc.2002-03-15
MEDTRONIC GEM ICD (P900061/S049)Medtronic Cardiac Rhythm Disease Management2002-03-13
KAPPA 400 PACEMAKER FAMILY (P970012/S013)Medtronic, Inc.2002-03-13
MEDTRONIC/VITATRON CARELINK PROGRAMMER (P890003/S065)Medtronic, Inc.2002-03-13
ACTIVITRAX PACEMAKER FAMILY (P850051/S057)Medtronic, Inc.2002-03-13
DEMA/DIVA IMPLANTABLE PULSE GENERATORS (P990001/S009)Medtronic, Inc.2002-03-13
LEGEND PLUS PACEMAKER FAMILY (P930022/S001)Medtronic, Inc.2002-03-13
GEM & MARQUIS FAMILY ICD'S (P980016/S027)Medtronic Cardiac Rhythm Disease Management2002-03-13
MEDTRONIC KAPPA/SIGMA PACEMAKER FAMILIES (P980035/S022)Medtronic, Inc.2002-03-13
MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM (P010015/S006)Medtronic, Inc.2002-03-13
MEDTRONIC JEWEL/GEM ICD'S (P980050/S012)Medtronic, Inc.2002-03-13
TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P000009/S003)Biotronik, Inc.2002-03-11
BELOS VR ICD SYSTEM (P980023/S006)Biotronik, Inc.2002-03-11
RIATA SERIES 1500 DEFIBRILLATION LEAD SYSTEM (P950022/S014)ABBOTT MEDICAL2002-03-11
VASOSEAL VHD & ES DEVICES (P920004/S016)St. Jude Medical, Inc.2002-03-07
ON-X PROSTHETIC HEART VALVE (P000037/S001)On-X Life Technologies, Inc.2002-03-06
BX VELOCITY BALLOON-EXPANDABLE STENT WITH RAPTOR OVER THE WIRE DELIVERY SYSTEM/BX VELOCITY WITH HEPACOAT ON RAPTOR STENT (P900043/S034)Cordis Corp.2002-03-05
BX VELOCITY STENT ON RAPTORRAIL/WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM (P900043/S033)Cordis Corp.2002-03-05
ST. JUDE MEDICAL REGENT MECHANICAL HEART VALVE (AORTIC) (P810002/S057)ABBOTT MEDICAL2002-03-04
S7 W/DISCRETE TECHNOLOGY(TM)OTW/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S031)Medtronic, Ireland2002-03-01
PHOTON MICRO MODEL V-194, V-232 AND ATLAS MODEL V-199 , V-240 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910023/S060)ABBOTT MEDICAL2002-03-01
MARQUIS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980016/S023)Medtronic Cardiac Rhythm Disease Management2002-03-01
MEDTRONIC PACING LEADS (P890003/S068)Medtronic, Inc.2002-03-01
BIODIVYSIO OC/OTW STENT SYSTEM (P000011/S004)Abbott Vascular, Inc.2002-03-01
MEDTRONIC KAPPA 900/800 SERIES PLUSE GENERATORS (P980035/S020)Medtronic, Inc.2002-02-26
POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS (P810046/S211)Advanced Cardiovascular Systems, Inc.2002-02-22
KENTROX RV LEAD SYSTEMS (P980023/S007)Biotronik, Inc.2002-02-21
BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES GOLD PLATING PROCESS/FLOPPY GOLD (P900056/S068)Boston Scientific Corp2002-02-21
MAVERICK MONORAIL PTCA CATHETERS (P860019/S178)Scimed Life Systems, Inc.2002-02-21
MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER (P920032/S008)Pace Medical2002-02-20
SCIMEN RADIUS STENT WITH MONORAIL DELIVERY SYSTEM (P970061/S014)Boston Scientific Scimed, Inc.2002-02-15
CUTTING BALLOON MONORAIL (P950020/S004)Boston Scientific Corp2002-02-15
POWERSAIL/HIGHSAIL CORONARY DILATATION CATHETER (P810046/S210)Advanced Cardiovascular Systems, Inc.2002-02-15
STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S002)Biosense Webster, Inc.2002-02-15
ANCURE ENDOGRAFT SYSTEM (P990017/S031)Boston Scientific Corp2002-02-14
PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS (P990001/S011)Medtronic, Inc.2002-02-13
GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER (P850049/S008)Cook, Inc.2002-02-13
GIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT (P910030/S009)Cook, Inc.2002-02-13
INOUE BALLOON CATHETER (P910054/S002)Toray Industries (America), Inc.2002-02-13
PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS (P960043/S037)Abbott Vascular, Inc.2002-02-13
PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S001)Edwards Lifesciences, LLC2002-02-12
RAPTORAIL PTCA DILATATION CATHETER (RX) (P880003/S083)Cordis Corp.2002-02-12
WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S012)Boston Scientific Corp2002-02-12
WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S010)Boston Scientific Scimed, Inc.2002-02-12
NOVOSTE BETA-CATH 3.5 FR SYSTEM (P000018/S015)Best Vascular, Inc.2002-02-08
ANEURX STENT GRAFT SYSTEM (P990020/S006)Medtronic Vascular2002-02-07
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