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Cardiovascular

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

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RecordFirmDate
KAPPA 900/800 IMPLANTABLE PULSE GENERATOR FAMILY SERIES (P980035/S018)Medtronic, Inc.2002-02-07
THE CLOSER/ CLOSER S THUMBCAP ASSEMBLY (P960043/S036)Abbott Vascular, Inc.2002-02-05
FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 6616 (P960006/S005)Boston Scientific2002-02-04
S660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM (P970035/S032)Medtronic, Ireland2002-01-31
BX VELOCITY STENT WITH HEPACOAT ON RAPTORAIL(RX)/RAPTOR(OTW) STENT DELIVERY SYSTEM (P900043/S032)Cordis Corp.2002-01-31
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S016)Thoratec Laboratories Corp.2002-01-30
NOVOSTE BETA-CATH SYSTEM (P000018/S016)Best Vascular, Inc.2002-01-30
STINGER S, STINGER M, STINGER SM ABLATION CATHETERS (P000020/S006)Boston Scientific Corp2002-01-28
16F LASER SHEATH ENHANCEMENT MODEL#500-013 (P960042/S007)Spectranetics (Philips)2002-01-25
CUTTING BALLOON (P950020/S003)Boston Scientific Corp2002-01-23
MAGIC WALLSTENT ENDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S013)Boston Scientific Scimed, Inc.2002-01-22
MAGIC WALLSTENT EDNDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P980009/S010)Boston Scientific Scimed, Inc.2002-01-22
MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS (P980016/S025)Medtronic Cardiac Rhythm Disease Management2002-01-18
MOSAIC PORCINE BIOPROSTHESIS (P990064/S006)Medtronic, Inc.2002-01-18
GEM III AT MODEL 7276 (P980050/S011)Medtronic, Inc.2002-01-18
MULTI-LINK RX PENTA CORONARY STENT SYSTEM (P970020/S036)Abbott Vascular, Inc.2002-01-14
ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM (P970020/S035)Abbott Vascular, Inc.2002-01-14
HALL EASY-FIT PROSTHETIC HEART VALVE (P790018/S042)Medtronic Cardiac Surgery2002-01-11
ENDOTAK: DSP, ENDURANCE EZ, AND ENDURANCE RX LEADS (P910073/S038)Boston Scientific2002-01-11
ORCHESTRA PROGRAMMER (P980049/S007)MicroPort CRM USA, Inc.2002-01-11
WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (P940019/S009)Boston Scientific Scimed, Inc.2002-01-10
WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (P980033/S001)Boston Scientific Corporation2002-01-10
WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (P930031/S011)Boston Scientific Corp2002-01-10
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES (P900056/S067)Boston Scientific Corp2002-01-09
CHILLI COOLED ABLATION SYSTEM (P990054/S003)Boston Scientific Corp2002-01-08
CHILLI COOLED ABLATION SYSTEM (P980003/S004)Boston Scientific Corp2002-01-08
THERA/THERA-I (P890003/S067)Medtronic, Inc.2002-01-03
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S007)Vascular Solutions, Inc.2001-12-31
MEDTRONIC SIGMA AND MEDTRONIC 350 SERIES PULSE GENERATORS (P980035/S017)Medtronic, Inc.2001-12-28
THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S035)Abbott Vascular, Inc.2001-12-28
ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P830045/S080)St. Jude Medical, Inc.2001-12-21
ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P880086/S087)ABBOTT MEDICAL2001-12-21
NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER (P790017/S073)Medtronic, Ireland2001-12-21
ATLAS DR/VR IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR (P910023/S058)ABBOTT MEDICAL2001-12-21
MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE (P980016/S021)Medtronic Cardiac Rhythm Disease Management2001-12-21
ALTO ICD MODELS 614 AND 615 (P980049/S006)MicroPort CRM USA, Inc.2001-12-21
PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C) (P000011/S003)Abbott Vascular, Inc.2001-12-21
MEDTRONIC CAPSURE SP MODEL 5024M (P930039/S013)Medtronic, Inc.2001-12-19
CAPSURE SP MODEL 5024M AND SUREFIX MODEL 5072 LEADSRIES (P850089/S050)Medtronic Cardiac Rhythm Disease Management2001-12-19
MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE (P790018/S040)Medtronic Cardiac Surgery2001-12-19
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S016)Boston Scientific Corp2001-12-18
GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S001)Guidant Corp.2001-12-18
FINELINE II STEROX LEADS (P960004/S020)Boston Scientific2001-12-18
WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030)Zoll Manufacturing Corporation2001-12-18
GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S003)Guidant Corp.2001-12-17
ANCURE ENDOGRAFT SYSTEM (P990017/S028)Boston Scientific Corp2001-12-17
MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM (P980035/S014)Medtronic, Inc.2001-12-14
THERA/THERA-I FAMILY OF PULSE GENERATORS (P890003/S066)Medtronic, Inc.2001-12-11
CAPSURE AND CAPSURE NOVUS FAMILIES OF LEADS/ACCESSORIES (P850089/S049)Medtronic Cardiac Rhythm Disease Management2001-12-11
DEMA/DIVA IMPLANTABLE PULSE GENERATORS (P990001/S010)Medtronic, Inc.2001-12-11
CAPSURE EPI 4965/4968 (P950024/S005)Medtronic, Inc.2001-12-11
SPRINT FAMILY OF LEADS (P920015/S025)Medtronic, Inc.2001-12-11
ANCURE ENDOGRAFT SYSTEM (P990017/S029)Boston Scientific Corp2001-12-11
KAPPA 400 (P970012/S012)Medtronic, Inc.2001-12-11
GEM III AT MODEL 7276 ICD/PULSE GENERATORS (P980050/S010)Medtronic, Inc.2001-12-11
CAPSUREFIX FAMILY OF LEADS (P930039/S012)Medtronic, Inc.2001-12-11
INSYNC IPG MODEL 8040 BIVENTRICULAR PULSE GENERATOR SYSTEM (P010015/S002)Medtronic, Inc.2001-12-11
GEM II FAMILY OF ICD/PULSE GENERATORS (P980016/S024)Medtronic Cardiac Rhythm Disease Management2001-12-11
CAPSURE FAMILY OF LEADS/ACCESSORIES (P830061/S033)Medtronic Cardiac Rhythm Disease Management2001-12-11
KAPPA 700/600, SIGMA AND 350 SERIES FAMILIES OF PULSE GENERATORS (P980035/S016)Medtronic, Inc.2001-12-11
MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700 (P790018/S038)Medtronic Cardiac Surgery2001-12-11
GEM ICD/IPG (P900061/S051)Medtronic Cardiac Rhythm Disease Management2001-12-11
CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049)Nmt Medical, Inc.2001-12-05
THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039)ABBOTT MEDICAL2001-12-05
FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM (P890043/S037)Abbott Vascular2001-12-05
MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700 (P790018/S039)Medtronic Cardiac Surgery2001-12-04
BIOGLUE SURGICAL ADHESIVE (P010003)Cryolife, Inc.2001-12-03
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S015)Thoratec Laboratories Corp.2001-11-30
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S016)Edwards Lifesciences, LLC2001-11-29
RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM (P970061/S012)Boston Scientific Scimed, Inc.2001-11-29
ECLIPSE TMR HOLMIUM LASER SYSTEM (P970029/S008)Cryolife, Inc.2001-11-29
THE CLOSER AND CLOSER S SUTURE MEDIATED CLOSURE DEVICES (P960043/S033)Abbott Vascular, Inc.2001-11-28
IDENTITY SR MODEL 5172 PULSE GENERATOR (P910023/S057)ABBOTT MEDICAL2001-11-27
IDENTITY XL DR MODEL 5376 PULSE GENERATOR (P880086/S086)ABBOTT MEDICAL2001-11-27
IDENTITY PULSE GENERATOR MODEL DR 5370 (P830045/S079)St. Jude Medical, Inc.2001-11-27
TALENT AND BRIO PACEMAKERS (P950029/S015)MicroPort CRM USA, Inc.2001-11-26
MOSAIC PORCINE BIOPROSTHESIS (P990064/S005)Medtronic, Inc.2001-11-21
BARD STINGER AND STINGER S ABLATION CATHETER AND TEMPLINK EXTENSION CABLE (P000020/S005)Boston Scientific Corp2001-11-21
ANGIOJET(R) RHEOLYTIC THROMBECTOMY SYSTEM DRIVE UNIT (P980037/S003)Boston Scientific Corp2001-11-20
CLOSER / CLOSER S 6 FRENCH SMC SYSTEMS (P960043/S031)Abbott Vascular, Inc.2001-11-20
ANGIOJET RHEOLYTIC XMI THROMBECTOMY CATHETER (P980037/S004)Boston Scientific Corp2001-11-20
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S011)Medtronic, Inc.2001-11-16
WALLSTENT ENDOPROSTHESIS (P980033)Boston Scientific Corporation2001-11-16
MEDTRONIC GEM ICD (P900061/S050)Medtronic Cardiac Rhythm Disease Management2001-11-14
HALL (TM) EASY-FIT PROSTHETIC HEART VALVE (P790018/S037)Medtronic Cardiac Surgery2001-11-09
MAVERICK OVER THE WIRE PTCA CAHTHETER (P860019/S177)Scimed Life Systems, Inc.2001-11-08
DIAGNOSTIC DUETT (P990037/S001)Vascular Solutions, Inc.2001-11-02
MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD (P920015/S024)Medtronic, Inc.2001-11-02
GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052)Guidant Corp.2001-11-02
ECLIPSE TMR HOLMIUM LASER SYSTEM (P970029/S007)Cryolife, Inc.2001-11-01
FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY, MODEL 995MS (P970031/S010)Medtronic, Inc.2001-10-31
MEDTRONIC KAPPA 700/600 PULSE GENERATOR (P980035/S015)Medtronic, Inc.2001-10-31
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S005)Vascular Solutions, Inc.2001-10-31
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S013)Thoratec Laboratories Corp.2001-10-31
BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170 (P920032/S007)Pace Medical2001-10-26
AXIOS PULSE GENERATOR FAMILY/B-K05.S.U PROGRAMMER SOFTWARE (P950037/S022)Biotronik, Inc.2001-10-26
VENTAK PRIZM II AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM (P960040/S024)Boston Scientific2001-10-26
THINLINE II/FINELINE II AND THINLINE II/FINELINE II STEROX LEADS (P960004/S019)Boston Scientific2001-10-26
NOVOSTE BETA-CATH SYSTEM (P000018/S009)Best Vascular, Inc.2001-10-26
NOVOSTE BETA-CATH SYSTEM (P000018/S008)Best Vascular, Inc.2001-10-26
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