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Cardiovascular

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

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RecordFirmDate
MEDTRONIC VISION SOFTWARE SERIES 4.0 (P900061/S043)Medtronic Cardiac Rhythm Disease Management2001-03-15
MEDTRONIC VISION SOFTWARE SERIES 4.0 (P980016/S017)Medtronic Cardiac Rhythm Disease Management2001-03-15
BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S035)Abiomed Cardiovascular, Inc.2001-03-15
BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022/S002)Medtronic Vascular2001-03-15
VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE (P990037/S002)Vascular Solutions, Inc.2001-03-14
VASOSEAL EXTRA SECURITY (ES) DEVICE (P920004/S014)St. Jude Medical, Inc.2001-03-13
ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S034)Abiomed Cardiovascular, Inc.2001-03-12
ANGIO-SEAL(TM) VASCULAR CLOSURE DEVICE, 8F/6F (P930038/S030)Terumo Medical Corporation2001-03-12
BETA-CATH(TM) SYSTEM (P000018/S010)Best Vascular, Inc.2001-03-09
MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953 - SERIES 1.1 SOFTWARE (P980035/S009)Medtronic, Inc.2001-03-08
MEDTRONIC KAPPA 400 PACING SYSTEM WITH MODEL 9952 VISION - SERIOE 1.3 SOFTWARE (P970012/S010)Medtronic, Inc.2001-03-08
DEMA, DIVA AND AFM PULSE GENERATORS (P990001/S006)Medtronic, Inc.2001-03-07
TACHOS DR, TACHOS DR- ATRIAL TX,TACHOS ATX (P000009/S001)Biotronik, Inc.2001-03-05
TCI HEARTMATE VE LVAS (P920014/S014)Thoratec Corp2001-03-02
VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE (P880086/S082)ABBOTT MEDICAL2001-03-02
MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM (P970020/S028)Abbott Vascular, Inc.2001-03-02
POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER (P810046/S204)Advanced Cardiovascular Systems, Inc.2001-03-02
VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE (P910023/S051)ABBOTT MEDICAL2001-03-02
VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE (P830045/S075)St. Jude Medical, Inc.2001-03-02
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007)Edwards Lifesciences, LLC2001-02-27
DISCOVERY(TM)/MERIDIAN(TM) (P940031/S025)Boston Scientific2001-02-26
MULTI-LINK RX TETRA CORONARY STENT SYSTEM (P970020/S029)Abbott Vascular, Inc.2001-02-26
SMARTMAGNET(TM) (P980016/S013)Medtronic Cardiac Rhythm Disease Management2001-02-22
NIR PREMOUNTED STENT SYSTEMS (P980001/S028)Boston Scientific Corp2001-02-21
CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S022)Corcym S.r.l.2001-02-16
NIR ELITE MONORAIL AND OVER-THE-WIRE(OTW) STENT SYSTEMS (P980001/S024)Boston Scientific Corp2001-02-16
NIROYAL(TM) ELITE OVER-THE-WIRE(OTW) STENT SYSTEM (P980001/S022)Boston Scientific Corp2001-02-16
CHILLI COOLED ABLATION SYSTEM (P990054/S001)Boston Scientific Corp2001-02-15
ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEMS (P990017/S012)Boston Scientific Corp2001-02-15
THINLINE II/FINELINE II STEROX PACING LEADS (P960004/S017)Boston Scientific2001-02-15
BETA-CATH(TM)SYSTEM (P000018/S007)Best Vascular, Inc.2001-02-13
MEDTRONIC GEM III AT MODEL 7276 (ICD) (P980050/S002)Medtronic, Inc.2001-02-13
STINGER(TM) M ABLATION CATHETER/TEMPLINK(TM) M EXTENSION CABLE (P000020/S002)Boston Scientific Corp2001-02-07
LYRA(TM) ICD SYSTEMS (P970024/S004)MicroPort CRM USA, Inc.2001-02-06
PHILOS PACING SYSTEM (P950037/S018)Biotronik, Inc.2001-02-05
MEDTRONIC MODEL 6725 PIN-PLUG FOR IS-1 PORT (P920015/S020)Medtronic, Inc.2001-02-05
BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE (P950029/S013)MicroPort CRM USA, Inc.2001-02-02
BX VELOCITY(TM) STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM (P900043/S025)Cordis Corp.2001-02-02
THE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM (P960043/S030)Abbott Vascular, Inc.2001-02-02
VENTAK(R) PRIZM(TM) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD-TM) SYSTEM (P960040/S020)Boston Scientific2001-02-01
ORCHESTRA PROGRAMMER (P980049/S004)MicroPort CRM USA, Inc.2001-01-31
NOVOSTE BETA-CATH SYSTEM (P000018/S006)Best Vascular, Inc.2001-01-29
HEART LASER 2 (HL2) (P950015/S008)Laser Engineering Heart, Inc.2001-01-29
NIROYAL(R) ELITE PREMOUNTED STENT SYSTEM (P980001/S023)Boston Scientific Corp2001-01-25
CROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS (P810046/S205)Advanced Cardiovascular Systems, Inc.2001-01-24
VENTAK AV FOR ASTRID (P960040/S019)Boston Scientific2001-01-23
VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 (P930035/S009)Boston Scientific2001-01-23
VENTAK MINI IV (AICD) (P910077/S036)Boston Scientific2001-01-23
ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S037)Boston Scientific2001-01-23
ANCURE ENDOGRAFT SYSTEM (P990017/S009)Boston Scientific Corp2001-01-19
CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM (P950022/S012)ABBOTT MEDICAL2001-01-18
CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM (P910023/S050)ABBOTT MEDICAL2001-01-18
LASER SHEATH (P960042/S006)Spectranetics (Philips)2001-01-17
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S028)Terumo Medical Corporation2001-01-16
NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER\ (P990025/S003)Biosense Webster, Inc.2001-01-11
RX CHASSIS I CORONARY DILATATION CATHETER (P810046/S203)Advanced Cardiovascular Systems, Inc.2001-01-11
(R) QUANTUM MONORAIL(TM) PTCA CATHETER (P860019/S167)Scimed Life Systems, Inc.2001-01-11
VITATRON DIVA PLATFORM (P990001/S005)Medtronic, Inc.2001-01-08
MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554 (P850089/S045)Medtronic Cardiac Rhythm Disease Management2001-01-08
D114S OTW BALLOON DILATATION CATHETER (P790017/S074)Medtronic, Ireland2001-01-08
STARR EDWARDS SILASTIC BALL VALVE (P870038/S004)Edwards Lifesciences, LLC2001-01-05
ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER (P900056/S059)Boston Scientific Corp2000-12-29
ANCURE ENDOGRAFT SYSTEM (P990017/S013)Boston Scientific Corp2000-12-28
NIR PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S027)Boston Scientific Corp2000-12-27
MICRONY PACEMAKERS (P970013)ABBOTT MEDICAL2000-12-21
S670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM (P000022/S003)Medtronic Vascular2000-12-19
S670/S660/BESTENT(TM)2/WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P970035/S023)Medtronic, Ireland2000-12-19
NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S002)Best Vascular, Inc.2000-12-18
SPRINT QUATTRO MODEL 6944 LEAD (P920015/S017)Medtronic, Inc.2000-12-15
BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM (P000022/S001)Medtronic Vascular2000-12-14
ALTO DR ICD (P980049/S003)MicroPort CRM USA, Inc.2000-12-14
NOVOSTE(TM) BETA-CATH(TM) SYSTEM (P000018/S001)Best Vascular, Inc.2000-12-13
DELTA/VISTA (P840068/S040)Boston Scientific2000-12-13
VENTAK AV DDD/AV II DDDD (P960040/S017)Boston Scientific2000-12-13
GEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD) (P980016/S015)Medtronic Cardiac Rhythm Disease Management2000-12-12
INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS (P880086/S081)ABBOTT MEDICAL2000-12-12
INTEGRITY DR MODEL 5336/INTEGRITY SR MODEL 5136 (P830045/S074)St. Jude Medical, Inc.2000-12-12
ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER (P900056/S058)Boston Scientific Corp2000-12-12
THE CLOSER(TM) AND THE CLOSER S(TM) DEVICES (P960043/S028)Abbott Vascular, Inc.2000-12-12
GEM II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDS (P980016/S008)Medtronic Cardiac Rhythm Disease Management2000-12-11
GEM MODEL 7227/MICROJEWEL MODELS 7221, 7223 ICDS (P900061/S039)Medtronic Cardiac Rhythm Disease Management2000-12-11
ECLIPSE TMR HOLMIUM LASER SYSTEM (P970029/S005)Cryolife, Inc.2000-12-08
MAXXUM AND NC MAXXUM PTCA CATHETER (P860019/S166)Scimed Life Systems, Inc.2000-12-08
TENDRILL PASSIVE PLUS/AU PLUS DX (P960030/S008)ABBOTT MEDICAL2000-12-07
TENDRIL SDX (P960013/S009)ABBOTT MEDICAL2000-12-07
VENTAK MINI IV (AICD) (P910077/S035)Boston Scientific2000-12-06
TETRA(TM) CORONARY STENT SYSTEM (P970020/S026)Abbott Vascular, Inc.2000-12-05
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S057)Boston Scientific Corp2000-12-05
LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM:THERMISTOR ONLY TEMPERATURE SENSING (P960016/S005)St Jude Medical2000-12-01
LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: 5MM TIP ELECTRODE (P960016/S006)St Jude Medical2000-12-01
ANGIO-SEAL VASCULAR DEVICE - 8F AND 6F (P930038/S026)Terumo Medical Corporation2000-11-29
STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE (P000020)Boston Scientific Corp2000-11-29
MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE (P980016/S014)Medtronic Cardiac Rhythm Disease Management2000-11-29
VENTRITEX ICD'S (P910023/S049)ABBOTT MEDICAL2000-11-27
VENTRITEX ICD'S (P830045/S073)St. Jude Medical, Inc.2000-11-27
MEDTRONIC MODEL 4806 ATAKR II RF POWER GENERATOR (P930029/S013)Medtronic, Inc.2000-11-27
VENTRITEX ICD'S (P880086/S080)ABBOTT MEDICAL2000-11-27
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S053)ABBOTT MEDICAL2000-11-21
AFFINITY FAMILY OF PULSE GENERATORS (P880086/S079)ABBOTT MEDICAL2000-11-21
CUTTING BALLOON (P950020/S001)Boston Scientific Corp2000-11-21
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