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Cardiovascular

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

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RecordFirmDate
ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEM (P990017/S010)Boston Scientific Corp2000-11-21
THINLINE II/ FINELINE II (P960004/S014)Boston Scientific2000-11-21
THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM (P870072/S010)Thoratec Laboratories Corp.2000-11-15
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S011)Thoratec Laboratories Corp.2000-11-15
VITATRON(R) DEMA PACING SYSTEM (P990001/S004)Medtronic, Inc.2000-11-13
ORCHESTRA PROGRAMMER (P980049/S002)MicroPort CRM USA, Inc.2000-11-13
MEDTRONIC HALL PROSTHETIC HEART VALVE (P790018/S036)Medtronic Cardiac Surgery2000-11-09
NIR(TM) PREMOUNTED STENT SYSTEMS (P980001/S026)Boston Scientific Corp2000-11-08
CROSS SAIL CORONARY DILATATION CATHETER (P810046/S202)Advanced Cardiovascular Systems, Inc.2000-11-03
BETA-CATH (TM) SYSTEM (P000018)Best Vascular, Inc.2000-11-03
CORDIS CHECKMATE(TM) SYSTEM (P990036)Cordis Corp.2000-11-03
RELIANCE/RELIANCE S (P910073/S035)Boston Scientific2000-11-02
PHILOS FAMILY OF PULSE GENERATORS (P950037/S016)Biotronik, Inc.2000-10-31
ANGIO-SEAL(TM) EV VASCULAR CLOSURE DEVICE/8 AND 6 FRENCH (P930038/S027)Terumo Medical Corporation2000-10-31
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S047)ABBOTT MEDICAL2000-10-27
ROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER (P900056/S056)Boston Scientific Corp2000-10-24
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S054)ABBOTT MEDICAL2000-10-23
TCI HEARTMATE VE LVAS (P920014/S013)Thoratec Corp2000-10-20
KNOT PUSHER WITH TRIMMER(TM) (P960043/S027)Abbott Vascular, Inc.2000-10-17
ANCURE ENDOGRAFT SYSTEM (P990017/S008)Boston Scientific Corp2000-10-16
BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022)Medtronic Vascular2000-10-16
ACTROS SLR PULSE GENERATOR (P950037/S013)Biotronik, Inc.2000-10-13
ATS OPEN PIVOT BILEAFLET HEART VALVE (P990046)Medtronic Ats Medical, Inc.2000-10-13
NIR PREMOUNTED STENT SYSTEMS (P980001/S025)Boston Scientific Corp2000-10-12
ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S036)Boston Scientific2000-10-12
ELA RATE-RESPONSIVE PACEMAKERS (P950029/S011)MicroPort CRM USA, Inc.2000-10-11
MEDTRONIC SIGMA SERIES PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM (P980035/S008)Medtronic, Inc.2000-10-10
TALENT AND BRIO PACEMAKERS (RIGID CONNECTOR) (P950029/S010)MicroPort CRM USA, Inc.2000-10-10
BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE (P860019/S162)Scimed Life Systems, Inc.2000-10-05
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S055)Boston Scientific Corp2000-10-05
ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S032)Boston Scientific2000-10-05
LEAD CAP ACCESSORY KIT (P940008/S015)Boston Scientific2000-10-05
MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM (P970020/S023)Abbott Vascular, Inc.2000-10-03
INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL (P830045/S072)St. Jude Medical, Inc.2000-10-02
INTEGRITY AFX DR/INTEGRITY SR (P880086/S078)ABBOTT MEDICAL2000-10-02
MEDTRONIC 9790/9790C PROGRAMMER (P890003/S061)Medtronic, Inc.2000-10-02
CLOSER S(TM) 6FR. SMC DEVICE (P960043/S026)Abbott Vascular, Inc.2000-09-29
PHYLAX AV ICD SYSTEM (P000009)Biotronik, Inc.2000-09-29
BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM (P000011)Abbott Vascular, Inc.2000-09-29
CORDIS WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S009)Biosense Webster, Inc.2000-09-29
NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S001)Biosense Webster, Inc.2000-09-28
THE HEART LASER(TM)CO2 TMR SYSTEM (P950015/S007)Laser Engineering Heart, Inc.2000-09-27
SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER (P860019/S160)Scimed Life Systems, Inc.2000-09-27
IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER (P910073/S034)Boston Scientific2000-09-25
VENTAK P MODEL 16OO (P890061/S013)Boston Scientific2000-09-25
TVL LEAD SYSTEM (P950022/S011)ABBOTT MEDICAL2000-09-25
ENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES (P910077/S033)Boston Scientific2000-09-25
THINLINE II/FINELINE II (P960004/S015)Boston Scientific2000-09-25
SWEET TIP RX STEROID ELUTING LEAD (P960006/S004)Boston Scientific2000-09-25
ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD (P950001/S008)Boston Scientific2000-09-25
MODEL 6577 STERILIZABLE TELEMETRY WAND (P830060/S049)Boston Scientific2000-09-25
NC NINJA PTCA DILATATION CATHETER (P880003/S081)Cordis Corp.2000-09-21
ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S054)Boston Scientific Corp2000-09-18
ELA RATE-RESPONSIVE PACEMAKERS (P950029/S012)MicroPort CRM USA, Inc.2000-09-13
IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER (P910073/S033)Boston Scientific2000-09-12
MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM (P970020/S021)Abbott Vascular, Inc.2000-09-08
V.1 2A PROGRAMMER SOFTWARE (P880006/S033)St. Jude Medical, Inc.2000-09-07
TRILOGY/SOLUS II/PARAGON III/PHOENIX III (P900070/S027)St. Jude Medical, Cardiac Rhythm Management Divisi2000-09-07
CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S048)ABBOTT MEDICAL2000-09-07
TENDRILL PASSIVE PLUS/AU PLUS DX (P960030/S007)ABBOTT MEDICAL2000-09-07
AV PLUS DX (P880086/S077)ABBOTT MEDICAL2000-09-07
TENDRIL SDX (P960013/S008)ABBOTT MEDICAL2000-09-07
V1. 2A PROGRAMMER SOFTWARE (P830045/S071)St. Jude Medical, Inc.2000-09-07
VENTRITEX TUL LEAD SYSTEM (P950022/S010)ABBOTT MEDICAL2000-09-07
CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS (P900060/S021)Corcym S.r.l.2000-09-05
PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE. (P950037/S015)Biotronik, Inc.2000-09-05
CAPSUREFIX(R) (P930039/S009)Medtronic, Inc.2000-08-31
MOSAIC PORCINE BIOPROSTHESIS (P990064/S002)Medtronic, Inc.2000-08-29
MOSAIC PORCINE BIOPROSTHESIS (P990064/S001)Medtronic, Inc.2000-08-29
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS (P860057/S011)Edwards Lifesciences, LLC2000-08-28
R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER (P790017/S071)Medtronic, Ireland2000-08-28
AV PLUS DX MODEL 1368 LEAD (P880086/S076)ABBOTT MEDICAL2000-08-25
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S053)Boston Scientific Corp2000-08-22
BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT (P970061/S009)Boston Scientific Scimed, Inc.2000-08-22
AFFINITY PULSE GENERATORS (P880086/S075)ABBOTT MEDICAL2000-08-15
VENTAK(R) PRIZM(TM) DR/VR HE SYSTEM (P960040/S016)Boston Scientific2000-08-07
VENTAK PRIZM 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE (P960040/S015)Boston Scientific2000-08-04
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S012)Edwards Lifesciences, LLC2000-08-04
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE (P860057/S014)Edwards Lifesciences, LLC2000-08-04
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S014)Edwards Lifesciences, LLC2000-08-04
VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER (P910001/S018)Spectranetics Corp.2000-08-04
NIROYAL(TM1) ELITE PREMOUNTED STENT SYSTEM (P980001/S017)Boston Scientific Corp2000-08-03
CLOSER (TM) SUTURE MEDIATED CLOSURE DEVICE (P960043/S025)Abbott Vascular, Inc.2000-08-03
ATAKR(R) RFCA ABLATION SYSTEM (P930029/S014)Medtronic, Inc.2000-07-31
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S049)Boston Scientific Corp2000-07-27
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S052)Boston Scientific Corp2000-07-27
VITATRON DIVA PACING SYSTEM (P990001/S003)Medtronic, Inc.2000-07-26
D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER (P790017/S072)Medtronic, Ireland2000-07-24
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S051)Boston Scientific Corp2000-07-24
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S050)Boston Scientific Corp2000-07-24
BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES (P900043/S024)Cordis Corp.2000-07-21
ROTABLATOR(R) ROTALINK (P900056/S048)Boston Scientific Corp2000-07-21
STOCKERT 70 RF GENERATOR AND ACCESSORIES/INTERFACE CABLE (P990071/S001)Biosense Webster, Inc.2000-07-21
8085 PREVAIL IMPLANTABLE PULSE GENERATOR (P850051/S055)Medtronic, Inc.2000-07-21
SYNERGYST II PMA FAMILY OF IMPLANTABLE PULSE GENERATORS (P890003/S060)Medtronic, Inc.2000-07-21
TCI HEARTMATE 1000A IP LVAS (P920014/S011)Thoratec Corp2000-07-20
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S025)Terumo Medical Corporation2000-07-17
NIR(R) PREMOUNTER STENT SYSTEMS (P980001/S021)Boston Scientific Corp2000-07-14
MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE (P990064)Medtronic, Inc.2000-07-14
VENTAK PRIZM DR/VR HE AICD (P960040/S014)Boston Scientific2000-07-13
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