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Cardiovascular

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

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RecordFirmDate
CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S005)Nmt Medical, Inc.2002-10-23
PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S001)Boston Scientific Scimed, Inc.2002-10-23
STOCKERT 70 RF GENERATOR WITH SOFTWARE VERSION 1.033 (P990071/S003)Biosense Webster, Inc.2002-10-21
S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N (P970035/S038)Medtronic, Ireland2002-10-15
ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC (P000037/S002)On-X Life Technologies, Inc.2002-10-11
THORATEC VENTRICULAR ASSIST DEVICE (P870072/S017)Thoratec Laboratories Corp.2002-10-09
LIFEVEST WCD 3000 SYSTEM (P010030/S001)Zoll Manufacturing Corporation2002-10-09
LIFEVEST WCD 3000 SYSTEM (P010030/S003)Zoll Manufacturing Corporation2002-10-09
BIOGLUE SURGICAL ADHESIVE (P010003/S002)Cryolife, Inc.2002-10-08
MODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM (P010012/S004)Boston Scientific Corp2002-10-07
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S020)Thoratec Laboratories Corp.2002-10-07
MODEL 2844 APPLICATION SOFTWARE, VERSION 3.5 (P960040/S027)Boston Scientific2002-10-07
MEDTRONIC AVE S660 ZIPPER MX CORONARY STENT SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM (P970035/S042)Medtronic, Ireland2002-10-02
SCIMED NC RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER (P860019/S180)Scimed Life Systems, Inc.2002-10-01
QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS (P860019/S182)Scimed Life Systems, Inc.2002-10-01
NOVOSTE BETA-CATH SYSTEM (P000018/S024)Best Vascular, Inc.2002-09-30
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S075)Boston Scientific Corp2002-09-30
LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S008)St Jude Medical2002-09-27
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S017)Boston Scientific Corp2002-09-27
NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER (P010068)Biosense Webster, Inc.2002-09-27
DIAGNOSTIC DUETT SEALING DEVICE, MODEL 2200; DIAGNOSTIC DUETT PRO SEALING DEVICE, MODEL 2210; AND D-STAT FLOWABLE HEMOS0 (P990037/S011)Vascular Solutions, Inc.2002-09-23
GALILEO (TM) III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S004)Guidant Corp.2002-09-19
STORMER ZIPPER MX BALLOON DILATATION CATHETER (P790017/S077)Medtronic, Ireland2002-09-18
QUICKSEAL ARTERIAL CLOSURE SYSTEM WITH Q-FOAM (P010049/S001)Sub-Q, Inc.2002-09-16
S7 WITH DISCRETE TECHNOLOGY OVER-THE -WIRE CORONARY STENT SYSTEM/S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY (P970035/S036)Medtronic, Ireland2002-09-13
MULTI LINK RX ZETA CORONARY STENT SYSTEM/ MULTI LINK OTW ZETA CORONARY STENT SYSTEM (P970020/S042)Abbott Vascular, Inc.2002-09-13
EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS (P020009)Boston Scientific Scimed, Inc.2002-09-11
ANCURE ENDOGRAFT SYSTEM (P990017/S035)Boston Scientific Corp2002-09-10
NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S007)Biosense Webster, Inc.2002-09-10
TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM (P000009/S004)Biotronik, Inc.2002-09-09
ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) (P980023/S010)Biotronik, Inc.2002-08-30
BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/ON RAPTORRAIL STENT DELIVERY SYSTEM (P900043/S041)Cordis Corp.2002-08-22
GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM (P000052/S005)Guidant Corp.2002-08-22
BX VELOCITY WITH HEPACOAT ON RAPTOR STENT SYSTEM (P900043/S037)Cordis Corp.2002-08-22
BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM, BX VELOCITY STENT ON RAPTORRAIL TX DELIVERY SYSTEM (P900043/S036)Cordis Corp.2002-08-22
THE PERCLOSE A-T (AUTO TIE) SMC DEVICE (P960043/S041)Abbott Vascular, Inc.2002-08-21
STINGER, STINGER M, STINGER S AND STINGER SM ABLATION CATHETERS WITH 8F/5MM DISTAL ELECTRODE (P000020/S007)Boston Scientific Corp2002-08-19
MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE (P880086/S089)ABBOTT MEDICAL2002-08-13
VASOSEAL ELITE VHD/ES DEVICE (P920004/S018)St. Jude Medical, Inc.2002-08-13
MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE (P830045/S082)St. Jude Medical, Inc.2002-08-13
MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE (P910023/S062)ABBOTT MEDICAL2002-08-13
GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S008)Guidant Corp.2002-08-09
ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS (P970020/S040)Abbott Vascular, Inc.2002-08-06
GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S010)Guidant Corp.2002-08-02
GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S006)Guidant Corp.2002-08-02
HEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM (P900043/S035)Cordis Corp.2002-08-02
BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM (P900043/S038)Cordis Corp.2002-08-02
SCIMED RADIUS STENT AND DELIVERY SYSTEM (P970061/S016)Boston Scientific Scimed, Inc.2002-07-31
NOVOSTE(TM) BETA-CATH SYSTEM (P000018/S023)Best Vascular, Inc.2002-07-31
ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235) (P910023/S061)ABBOTT MEDICAL2002-07-30
ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235) (P880086/S088)ABBOTT MEDICAL2002-07-30
ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235) (P830045/S081)St. Jude Medical, Inc.2002-07-30
BIOGLUE SURGICAL ADHESIVE (P010003/S001)Cryolife, Inc.2002-07-29
BIODIVYSIO SV OTW PHOSPHORYLCHOLINE COATED STENT DELIVERY SYSTEM (P000011/S006)Abbott Vascular, Inc.2002-07-26
CORDIS CHECKMATE SYSTEM (P990036/S003)Cordis Corp.2002-07-25
ENDOTAK RELIANCE/RELIANCE S STEROID ELUTING EXTENDABLE/RETRACTABLE HELIX ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S039)Boston Scientific2002-07-25
ANCURE ENDOGRAFT SYSTEM (P990017/S032)Boston Scientific Corp2002-07-25
MODELS S7, S670 AND S660 DISCRETE TECHNOLOGY OVER-THE-WIRE (P970035/S040)Medtronic, Ireland2002-07-24
ANCURE ENDOCRAFT SYSTEM (P990017/S034)Boston Scientific Corp2002-07-24
CAPSURE SENSE LEAD MODELS (P830061/S034)Medtronic Cardiac Rhythm Disease Management2002-07-23
VENTAK PRIZM 2 VR/DR MODELS 1860/1861; VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856; VENTAK PRIZM VR/DR HE MODELS 1852 (P960040/S026)Boston Scientific2002-07-18
VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/ (P910077/S037)Boston Scientific2002-07-18
CUTTING BALLOON (P950020/S005)Boston Scientific Corp2002-07-17
PALMAZ BALLOON-EXPANDABLE STENT (P890017/S010)Cordis US Corporation2002-07-10
CHILLI COOLED ABLATION SYSTEM (P990054/S004)Boston Scientific Corp2002-06-28
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WIRE (P900056/S074)Boston Scientific Corp2002-06-28
MULTI-LINK RX PIXEL/OTW PIXEL CORONARY STENT SYSTEM (P970020/S041)Abbott Vascular, Inc.2002-06-28
CHILLI COOLED ABLATION SYSTEM (P980003/S005)Boston Scientific Corp2002-06-28
NOVOSTE/BETA-CATH SYSTEM (P000018/S022)Best Vascular, Inc.2002-06-28
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S072)Boston Scientific Corp2002-06-27
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S073)Boston Scientific Corp2002-06-26
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031)Medtronic Cardiac Rhythm Disease Management2002-06-26
AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER (P880065/S007)Boston Scientific Corp2002-06-25
WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S003)Boston Scientific Corporation2002-06-25
BOSTON SCIENTIFIC/SCIMED PTCA/PERFUSION CATHETERS (P860019/S185)Scimed Life Systems, Inc.2002-06-25
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P880027/S062)Boston Scientific2002-06-25
NIR PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S040)Boston Scientific Corp2002-06-25
WALLSTENT TRANSJUGLAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS (P930031/S014)Boston Scientific Corp2002-06-25
RADIUS CORONARY STENT WITH DELIVERY SYSTEMS (P970061/S015)Boston Scientific Scimed, Inc.2002-06-25
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P860019/S184)Scimed Life Systems, Inc.2002-06-25
WALLSTENT ILLIAC ENDOPROSTHESIS (P940019/S012)Boston Scientific Scimed, Inc.2002-06-25
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) (P010041)Edwards Lifesciences, LLC2002-06-24
CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIKLOAD (P000049/S004)Nmt Medical, Inc.2002-06-19
QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM (P010049/S002)Sub-Q, Inc.2002-06-13
CORDIS CHECKMATE SYSTEM (P990036/S001)Cordis Corp.2002-06-13
MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218 (P890003/S069)Medtronic, Inc.2002-06-12
MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218 (P900061/S052)Medtronic Cardiac Rhythm Disease Management2002-06-12
VASOSEAL 4-5 FRENCH SYSTEM (P920004/S017)St. Jude Medical, Inc.2002-06-11
ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT (P990046/S005)Medtronic Ats Medical, Inc.2002-06-07
THE CLOSER S 6FR. SMC (P960043/S040)Abbott Vascular, Inc.2002-06-05
MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM (P010015/S004)Medtronic, Inc.2002-05-31
RF ENHANCER 7 FRENCH, 5 MM ABLATION CATHETER (P930029/S017)Medtronic, Inc.2002-05-31
BX VELOCITY BALLOON EXPANDABLE STENT WITH RAPTOR OTW DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTOR OTW (P900043/S040)Cordis Corp.2002-05-31
VASCULAR SOLUTION DUETT SEALING DEVICE (P990037/S008)Vascular Solutions, Inc.2002-05-29
ATS OPEN PIVOT BILEAFLET (P990046/S006)Medtronic Ats Medical, Inc.2002-05-29
MULTI-LINK RX TETRA/OTW TETRA CORONARY STENT SYSTEM (P970020/S039)Abbott Vascular, Inc.2002-05-23
MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEMS (P970020/S038)Abbott Vascular, Inc.2002-05-22
THE CLOSER AK 6 FR. SMC DEVICE (P960043/S039)Abbott Vascular, Inc.2002-05-21
CONTAK CD SYSTEM (P010012/S001)Boston Scientific Corp2002-05-20
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (P980033/S002)Boston Scientific Corporation2002-05-10
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Every clearance here is in the API, with alerts when new ones post.