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Cardiovascular

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

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RecordFirmDate
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S019)Edwards Lifesciences, LLC2003-05-09
MEDTRONIC MODEL CAPSUREEPI 4695 AND CAPSUREEPI 4968 (P950024/S006)Medtronic, Inc.2003-05-09
RESPONSE CV CATHETER SYSTEM (P020052)St Jude Medical2003-05-07
EXCLUDER BIFURCATED ENDOPROSTHEIS (P020004/S002)W. L. Gore & Associates, Inc.2003-05-05
CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S023)Spectranetics Corp.2003-05-02
STORMER Z BALLOON DILATATION/NC STORMER Z BALLOON DILATATION CATHETER (P790017/S080)Medtronic, Ireland2003-05-02
ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM (P930038/S036)Terumo Medical Corporation2003-05-02
S7 AND S660 ZIPPER MX CORONARY STENT SYSTEMS (P970035/S045)Medtronic, Ireland2003-05-02
CUTTING BALLOON ULTRA (P950020/S007)Boston Scientific Corp2003-04-30
ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S037)Abiomed Cardiovascular, Inc.2003-04-28
THORATEC VAD SYSTEM; SEALED ARTERIAL CANNULAE, 14 MM AND 18 MM GRAFT (P870072/S025)Thoratec Laboratories Corp.2003-04-25
INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM (P010031/S006)Medtronic Cardiac Rhythm Disease Management2003-04-24
QUICKSEAL II ARTERIAL CLOSURE SYSTEM (P010049/S006)Sub-Q, Inc.2003-04-24
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026)Cordis Corp.2003-04-24
EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P830045/S084)St. Jude Medical, Inc.2003-04-23
EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P880086/S092)ABBOTT MEDICAL2003-04-23
EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910023/S065)ABBOTT MEDICAL2003-04-23
VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P960040/S025)Boston Scientific2003-04-23
SOLOX VDD PACING LEAD (P950037/S024)Biotronik, Inc.2003-04-23
NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS (P990025/S006)Biosense Webster, Inc.2003-04-22
EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S003)W. L. Gore & Associates, Inc.2003-04-22
NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS (P950005/S016)Biosense Webster, Inc.2003-04-22
PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS,MODEL 6900P,MITRAL (P860057/S021)Edwards Lifesciences, LLC2003-04-18
7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045)Medtronic Cryocath, LP2003-04-17
S670 W/DISCRETE TECHNOLOGY(TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S039)Medtronic, Ireland2003-04-17
AT500DDDRP PACING SYSTEM & MODEL 9968 SOFTWARE (P980035/S027)Medtronic, Inc.2003-04-16
ISOFLEX S PERMANENT PACING LEAD MODELS (P960030/S010)ABBOTT MEDICAL2003-04-10
GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S017)Guidant Corp.2003-04-09
PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM (P960043/S044)Abbott Vascular, Inc.2003-04-04
THORETEC HEARTMATE XVE LVAS (P920014/S017)Thoratec Corp2003-04-04
VASOSEAL DEVICES (P920004/S019)St. Jude Medical, Inc.2003-04-03
SPRINT/SPRINT QUATTRO (P920015/S027)Medtronic, Inc.2003-04-03
CAPSURE FIX (P980016/S034)Medtronic Cardiac Rhythm Disease Management2003-04-03
CAPSURE SP NOVUS/Z NOVUS (P850089/S052)Medtronic Cardiac Rhythm Disease Management2003-04-03
CAPSURE FIX/NOVUS (P930039/S015)Medtronic, Inc.2003-04-03
CAPSURE SP/SENSE/SP NOVUS (P830061/S036)Medtronic Cardiac Rhythm Disease Management2003-04-03
WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S006)Boston Scientific Corporation2003-04-01
REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER (P860019/S194)Scimed Life Systems, Inc.2003-04-01
THORATEC HEARTMATE LVAS (P920014/S018)Thoratec Corp2003-04-01
LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S009)St Jude Medical2003-03-28
MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION 3 (P010031/S003)Medtronic Cardiac Rhythm Disease Management2003-03-27
VENTAK PRIZM AVT AICD SYSTEM (P960040/S028)Boston Scientific2003-03-27
INSYNC III MODEL 8042 ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE (P010015/S009)Medtronic, Inc.2003-03-27
VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812 (P960040/S029)Boston Scientific2003-03-26
MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE (P980035/S013)Medtronic, Inc.2003-03-26
EASYTRAK 3 PACING LEAD (P010012/S009)Boston Scientific Corp2003-03-25
RIATA DEFIBRILLATION LEAD SYSTEM MODEL 1572 AND 1582 (P950022/S016)ABBOTT MEDICAL2003-03-25
THORATEC HEARTMATE STROKE VOLUME LIMITER (P920014/S020)Thoratec Corp2003-03-21
VIGOR DR/SR AND DISCOVERY MERIDIAN AR (P940031/S027)Boston Scientific2003-03-21
VENTAK PRX AND MINI ICDS (P910077/S039)Boston Scientific2003-03-21
VENTAK AV AND VENTAK PRIZM DR/VR AICDS (P960040/S030)Boston Scientific2003-03-21
CONTAK CD (P010012/S007)Boston Scientific Corp2003-03-21
IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A (P910023/S066)ABBOTT MEDICAL2003-03-20
IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A (P880086/S093)ABBOTT MEDICAL2003-03-20
GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S018)Guidant Corp.2003-03-20
IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A (P830045/S085)St. Jude Medical, Inc.2003-03-20
NOVOSTE BETA-CATH 3.5 SYSTEM (P000018/S031)Best Vascular, Inc.2003-03-17
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S014)Vascular Solutions, Inc.2003-03-14
NOVOSTE BETA-CATH 3.5 SYSTEM (P000018/S032)Best Vascular, Inc.2003-03-13
QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM (P010049/S005)Sub-Q, Inc.2003-03-12
EXPRESS/EXPRESS2 MR/OTW CORONARY STENT SYSTEM (P020009/S006)Boston Scientific Scimed, Inc.2003-03-12
CUTTING BALLOON (P950020/S006)Boston Scientific Corp2003-03-11
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S076)Boston Scientific Corp2003-03-07
EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S007)Boston Scientific Scimed, Inc.2003-03-07
MODEL 7230 MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980016/S031)Medtronic Cardiac Rhythm Disease Management2003-03-06
NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER (P790017/S079)Medtronic, Ireland2003-03-04
MEDTRONIC ATAKR II MODEL 4802 (60W) SOFTWARE VERSION 1.36 (P930029/S020)Medtronic, Inc.2003-03-03
STINGER, STINGER S, STINGER M, AND STINGER SM ABLATION CATHETER (P000020/S008)Boston Scientific Corp2003-02-26
NOVOSTE TM BETA-CATH TM SYSTEM (P000018/S030)Best Vascular, Inc.2003-02-26
MAGIC WALLSTENT ENDOPROSTHESIS SYSTEM (P980009/S012)Boston Scientific Scimed, Inc.2003-02-26
MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) (P900061/S055)Medtronic Cardiac Rhythm Disease Management2003-02-25
INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE (P010015/S005)Medtronic, Inc.2003-02-25
MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) (P980035/S026)Medtronic, Inc.2003-02-25
CARDIOMESSENGER HOME MONITORING SYSTEM (P950037/S031)Biotronik, Inc.2003-02-25
MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) (P980016/S033)Medtronic Cardiac Rhythm Disease Management2003-02-25
TENDRIL SDX MODEL 1488T/TC/K (P960013/S011)ABBOTT MEDICAL2003-02-25
DUETT SEALING DEVICE (P990037/S013)Vascular Solutions, Inc.2003-02-21
GEM III AT 7276 (P980050/S013)Medtronic, Inc.2003-02-21
INSYNC IPG 8040 (P010015/S008)Medtronic, Inc.2003-02-21
KAPPA 700/600, 900/800, SIGMA/MEDTRONIC 350 (P980035/S025)Medtronic, Inc.2003-02-21
GEM III DR 7275, GEM III VR 7231, GEM DR 7271 (P980016/S030)Medtronic Cardiac Rhythm Disease Management2003-02-21
CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QUICK LOAD (P000049/S006)Nmt Medical, Inc.2003-02-21
INSYNC ICD 7272 (P010031/S004)Medtronic Cardiac Rhythm Disease Management2003-02-21
DIVA PLATFORM,DERMA PLATFORM (P990001/S013)Medtronic, Inc.2003-02-21
AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS (P000039/S004)ABBOTT MEDICAL2003-02-21
GEM MODEL 7227 CX/B/D/E (P900061/S053)Medtronic Cardiac Rhythm Disease Management2003-02-21
KAPPA 400 (P970012/S014)Medtronic, Inc.2003-02-21
SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD (P980049/S008)MicroPort CRM USA, Inc.2003-02-14
ST.JUDE MEDICAL EPIC/ATLAS DR/VR ICD (P910023/S064)ABBOTT MEDICAL2003-02-12
BLAZER RPM CARDIAC ABLATION CATHETERS (P920047/S018)Boston Scientific Corp2003-02-12
GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S011)Guidant Corp.2003-02-10
QUICKSEAL II ARTERIAL CLOSURE SYSTEM (P010049/S004)Sub-Q, Inc.2003-02-10
CELSIUS AND CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S017)Biosense Webster, Inc.2003-02-04
NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS (P010068/S001)Biosense Webster, Inc.2003-02-04
STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY (P790017/S078)Medtronic, Ireland2003-02-04
NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S008)Biosense Webster, Inc.2003-02-04
0.7 MM EXTREME CATHETER (P910001/S021)Spectranetics Corp.2003-02-04
EXCLUDER TM BIFURCATED ENDOPROSTHESIS (P020004/S001)W. L. Gore & Associates, Inc.2003-01-30
DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE (P990037/S012)Vascular Solutions, Inc.2003-01-30
BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER (P860019/S191)Scimed Life Systems, Inc.2003-01-27
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