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Cardiovascular

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

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RecordFirmDate
MEDTRONIC CAPSURE SP NOVUS (P850089/S041)Medtronic Cardiac Rhythm Disease Management1999-06-11
MEDTRONIC VISION SOFTWARE (MODEL 9953A) (P980035/S003)Medtronic, Inc.1999-06-11
NIR PRIMO PREMOUNTED STENT SYSTEM (P980001/S008)Boston Scientific Corp1999-06-11
TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S015)Abbott Vascular, Inc.1999-06-11
ACTROS DR+ -B PULSE GENERATOR (P950037/S009)Biotronik, Inc.1999-06-07
ACS OTW PHOTON CORONARY DILATATION CATHETER (P810046/S198)Advanced Cardiovascular Systems, Inc.1999-06-04
GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S011)Medtronic, Ireland1999-06-03
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003)Boston Scientific Corp1999-06-03
SULZER CARBOMEDICS CPHV OPTIFORM VALVE (P900060/S019)Corcym S.r.l.1999-06-01
TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S016)Abbott Vascular, Inc.1999-05-28
SCIMED REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER (P860019/S149)Scimed Life Systems, Inc.1999-05-28
PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY OVER THE WIRE DELIVERY SYSTEM (P900043/S016)Cordis Corp.1999-05-27
TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S018)Abbott Vascular, Inc.1999-05-26
NIR PRIMO PREMOUNTED STENT SYSTEM (P980001/S001)Boston Scientific Corp1999-05-20
ACA MULTI-LINK & DUET CSS (P970020/S015)Abbott Vascular, Inc.1999-05-20
ACS OTW SOLARIS CORONARY DILATATION CATHETER (P810046/S195)Advanced Cardiovascular Systems, Inc.1999-05-19
BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S029)Abiomed Cardiovascular, Inc.1999-05-19
GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM (P970035/S016)Medtronic, Ireland1999-05-14
ACS MULTI-LINK RX AND OTW DUET CORONARY STENT SYSTEM (P970020/S014)Abbott Vascular, Inc.1999-05-14
ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C (P880086/S038)ABBOTT MEDICAL1999-05-13
SCIMED PTCA CATHETERS (P860019/S153)Scimed Life Systems, Inc.1999-05-11
DISCOVERY & MERIDIAN PULSE GENERATORS (P940031/S018)Boston Scientific1999-05-06
CHILLI COOLED ABLATION SYSTEM (P980003/S002)Boston Scientific Corp1999-05-06
ACS MULTI-LINK RX DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS (P970020/S011)Abbott Vascular, Inc.1999-05-06
TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S009)Abbott Vascular, Inc.1999-05-05
TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S017)Abbott Vascular, Inc.1999-05-05
PERCLOSE PROSTAR XL 8 & 10 FRENCH PVS SYSTEM (P960043/S007)Abbott Vascular, Inc.1999-05-05
LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016)St Jude Medical1999-05-04
VENTAK VR OMDEL 1774/MODEL 1775 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH MODEL 2841 SOFTWARE APPLICATION (P960040/S009)Boston Scientific1999-05-03
GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S006)Medtronic, Ireland1999-04-27
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S018)Terumo Medical Corporation1999-04-27
THE HEART LASER CO2 TMR SYSTEM (P950015/S002)Laser Engineering Heart, Inc.1999-04-27
ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM (P970020/S012)Abbott Vascular, Inc.1999-04-22
MODEL 3510 PROGRAMMER/3303 SOFTWARE (P830045/S064)St. Jude Medical, Inc.1999-04-21
MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER (P880065/S004)Boston Scientific Corp1999-04-21
MODEL 3510 PROGRAMMER/ 3303 SOFTWARE (P880086/S060)ABBOTT MEDICAL1999-04-21
SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S002)Boston Scientific Scimed, Inc.1999-04-21
VENTRITEX CONTOUR II/MD; ANGSTROM II/MD; PROFILE II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR (P910023/S042)ABBOTT MEDICAL1999-04-19
VENTRITEX CONTOUR II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR (P910023/S041)ABBOTT MEDICAL1999-04-19
PHYLAX ICD (P980023/S001)Biotronik, Inc.1999-04-19
ST. JUDE MEDICAL MASTERS SERIES MECHANICAL HEART VALVE (P810002/S048)ABBOTT MEDICAL1999-04-16
PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY (P900043/S013)Cordis Corp.1999-04-15
GEM II DR MODEL 7273 (P980016/S005)Medtronic Cardiac Rhythm Disease Management1999-04-15
GEM MODEL 7227 CX ICD (P900061/S037)Medtronic Cardiac Rhythm Disease Management1999-04-15
ACS RX SOLARIS CORONARY DILATATION CATHETER (P810046/S194)Advanced Cardiovascular Systems, Inc.1999-04-14
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S010)Boston Scientific Corp1999-04-14
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE (P860057/S010)Edwards Lifesciences, LLC1999-04-13
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S009)Edwards Lifesciences, LLC1999-04-13
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S011)Edwards Lifesciences, LLC1999-04-13
SWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD (P960006/S001)Boston Scientific1999-04-09
SCIMED PTCA CATHETER (P860019/S155)Scimed Life Systems, Inc.1999-04-09
LOCATOR STEERABLE STYLET (P960013/S005)ABBOTT MEDICAL1999-04-09
TECHSTAR XL & PROSTAR XL PERCTANEOUS VASCULAR SURGICAL DEVICE (P960043/S011)Abbott Vascular, Inc.1999-04-09
GFX-XP/GFX2 CORONARY STENT SYSTEM (P970035/S008)Medtronic, Ireland1999-04-08
SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S150)Scimed Life Systems, Inc.1999-04-08
ADANTE PTCA CATHETER (P860019/S154)Scimed Life Systems, Inc.1999-04-05
CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE (P950005/S004)Biosense Webster, Inc.1999-04-05
MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953-SERIES 1.1 SOFTWARE (P980035/S001)Medtronic, Inc.1999-04-01
PALMAZ-SCHATZ CROWN STENT WITH POWERGRIP OTW DELIVERY SYSTEM (P900043/S014)Cordis Corp.1999-03-31
RES-Q MICRON ADVANTAGE (P940008/S012)Boston Scientific1999-03-31
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S012)Boston Scientific Corp1999-03-30
WALLSTENT ILIAC ENDOPROSTHESIS (P940019/S004)Boston Scientific Scimed, Inc.1999-03-30
TVL LEAD SYSTEM (P950022/S005)ABBOTT MEDICAL1999-03-26
CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S040)ABBOTT MEDICAL1999-03-26
TCI HEARTMATE IP LVAS (P920014/S008)Thoratec Corp1999-03-25
POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT (P980017/S001)Possis Medical, Inc.1999-03-24
THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM (P870072/S009)Thoratec Laboratories Corp.1999-03-19
VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P910077/S027)Boston Scientific1999-03-17
SULZER CARBOMEDICS ORBIS PROSTHETIC HEART VALVE (P900060/S018)Corcym S.r.l.1999-03-17
MEDTRONIC KAPPA 400 SERIES IPG'S (P970012/S008)Medtronic, Inc.1999-03-12
ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER (P980037)Boston Scientific Corp1999-03-12
VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008 (P910001/S013)Spectranetics Corp.1999-03-12
NIR ON RANGER AND NIR ON RANGER WITH/SOX (P980001/S004)Boston Scientific Corp1999-03-10
LYRA IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR:ANGEPASS DEFIBRILLATION LEAD SYSTEM (P970024/S001)MicroPort CRM USA, Inc.1999-03-05
MEDTRONIC MODEL 6940 STERIOC ELUTING BIPOLAR IMPALNTABLE SCREW-IN VENTRICULAR/ATRIAL TRANSVENOUS LEAD (P980016/S004)Medtronic Cardiac Rhythm Disease Management1999-03-05
ACS RX GEMINI CORONARY DILATATION CATHETER (P810046/S197)Advanced Cardiovascular Systems, Inc.1999-03-04
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S039)ABBOTT MEDICAL1999-03-01
SCIMED SINGLE OPERATOR EXCHANGE PTCA CATHETERS (P860019/S152)Scimed Life Systems, Inc.1999-02-26
NIR PREMOUNTED STENT SYSTEM (P980001/S003)Boston Scientific Corp1999-02-25
MULTI-PARTITION OPERATING ENVIRONMENT (MOE), VERSION 1.0 (P970024/S002)MicroPort CRM USA, Inc.1999-02-23
TECHSTAR/PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S012)Abbott Vascular, Inc.1999-02-19
RX 7000 PROGRAMMING SYSTEM (P830026/S074)Boston Scientific1999-02-18
ACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS (P970020/S005)Abbott Vascular, Inc.1999-02-18
MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT (P980009/S003)Boston Scientific Scimed, Inc.1999-02-17
CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S038)ABBOTT MEDICAL1999-02-12
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S013)Terumo Medical Corporation1999-02-12
TMR HOLMIUM LASER SYSTEM (P970029)Cryolife, Inc.1999-02-11
SCIMED RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM (P970061/S005)Boston Scientific Scimed, Inc.1999-02-11
ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S025)Boston Scientific Corp1999-02-09
14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE (P960042/S003)Spectranetics (Philips)1999-02-08
PALMAZ BALLON-EXPANABLE STENT (P890017/S006)Cordis US Corporation1999-02-05
SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S001)Boston Scientific Scimed, Inc.1999-02-04
ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM (P970020/S002)Abbott Vascular, Inc.1999-02-03
CHILLI COOLED RF ABLATION SYSTEM (P980003)Boston Scientific Corp1999-02-02
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024/S003)Medtronic, Inc.1999-02-01
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035)Medtronic, Inc.1999-01-29
MEDTRONIC MODEL 7273 GEM II DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9964 (GEM II DR) AP (P980016/S002)Medtronic Cardiac Rhythm Disease Management1999-01-28
ACS MULTI-LINK STENTS (P970020/S009)Abbott Vascular, Inc.1999-01-28
ENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS (P910073/S025)Boston Scientific1999-01-27
MAGIC WALLSTENT ENDOPROTHESIS NATIVE CORONARY INDICATION (P980009/S001)Boston Scientific Scimed, Inc.1999-01-27
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