meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
1991-05-02

Clearances · page 135 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K910661 MODEL 205 SHOCK-TRODE Cardiotronics, Inc. DRO Class II 1991-05-02
K910049 INTERSPEC APOGEE, MODIFICATION Interspec, Inc. DPW Class II 1991-04-29
K910372 INTIMAX THROMBECTOMY CATHETER Applied Vascular Devices, Inc. DXE Class II 1991-04-26
K910490 MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A Hewlett-Packard Co. DSI Class II 1991-04-26
K900366 ARRHYTHMIA 9215 S & W Medico Teknik DSI Class II 1991-04-26
K911527 NOVOSTE GUIDING CATHETER Novoste Corp. DQY Class II 1991-04-24
K910204 SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) Baxter Healthcare Corp DQO Class II 1991-04-24
K910291 MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION Hewlett-Packard Co. DSI Class II 1991-04-22
K911462 SURGICAL TROCAR Applied Medical DRC Class II 1991-04-22
K903948 INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. DTB Class III 1991-04-22
K910764 THE PERCEPTOR(TM) STAND ALONE TRANSDUCER North American Instrument Corp. DRS Class II 1991-04-22
K904832 MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST Hewlett-Packard Co. DXK Class II 1991-04-22
K910378 PRESSURE MONITORING EXTENSION LINE Professional Medical Services DQO Class II 1991-04-22
K910494 RESTING EKG ELECTRODE SERIES Medtronic Andover Medical, Inc. DRX Class II 1991-04-22
K910280 ULTRA-SELECT PTCA GUIDEWIRE Microvena Corp. DQX Class II 1991-04-19
K905528 URESIL VALVE CUTTER Uresil Corp. DWQ Class II 1991-04-18
K911048 MODEL 5857-3M LEAD END CAP KIT Medtronic Vascular DTD Class II 1991-04-18
K910630 MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT Medtronic Vascular DTD Class II 1991-04-18
K910259 SCHNEIDER MAGNARAIL PROBING CATHETER Schneider Intl., Ltd. DQO Class II 1991-04-18
K910521 SYSTEM 7300 PULSE OXIMETER Advanced Medical Instruments, Inc. DQA Class II 1991-04-18
K910307 CARDIOLAB AMPLIFIER MODULE (CAM) Prucka Engineering, Inc. DRR Class II 1991-04-12
K904984 ADVANCE 418(TM) Peripheral Systems Group LIT Class II 1991-04-12
K910772 PROPAQ 102, 104 AND 106 Protocol Systems, Inc. DXN Class II 1991-04-12
K904618 CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. DQO Class II 1991-04-12
K905065 DEFIBRILLATOR LEAD ADAPTER Spacelabs, Inc. LDD Class II 1991-04-12
K910107 DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD Baxter Healthcare Corp DTZ Class II 1991-04-10
K910995 MEDI-TECH BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1991-04-09
K911203 TEGWIRE (TM) Boston Scientific Corp LIT Class II 1991-04-09
K910923 BCD ADVANCED Shiley, Inc. DTR Class II 1991-04-09
K910568 MODEL 5866-46 SLEEVE KIT Medtronic Vascular DTP Class II 1991-04-09
K905487 VARIOUS TYPES OF STETHOSCOPES Liaoning-Usa Corp. LDE Class I 1991-04-09
K910996 OPTI-PLAST 5F PTA CATHETERS Vas-Cath, Inc. LIT Class II 1991-04-09
K903894 VENAPULSE MODELS VP-25 AND VP-50 Aci Medical, Inc. JOW Class II 1991-04-03
K905269 OCHSNER 500 VASCULAR PROSTHESIS Intervascular, Inc. DSY Class II 1991-04-02
K904508 CONDOR ANALOG INFLATION SYRINGE Professional Medical Services MAV Class II 1991-04-02
K910863 EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS Vascutek, Ltd. DSY Class II 1991-04-01
K910865 TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS Vascutek, Ltd. DSY Class II 1991-04-01
K905447 E-Z-EM PULSED INFUSION SYSTEM E-Z-Em, Inc. KRA Class II 1991-04-01
K910866 VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS Vascutek, Ltd. DSY Class II 1991-04-01
K910208 BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS Baxter Healthcare Corp DQO Class II 1991-04-01
K910864 EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS Vascutek, Ltd. DSY Class II 1991-04-01
K910262 KELLER VITAL SIGNS MONITOR - KMS-890 Keller Medical Specialties Products, Inc. DSJ Class II 1991-04-01
K904475 ENTREE SHEATH INTRODUCER SYSTEM Cordis Corp. DYB Class II 1991-04-01
K905831 ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH Arzco Medical Electronics, Inc. DRF Class II 1991-03-29
K905411 FLOWIRE AND FLOMAP Cardio Metrics, Inc. DPW Class II 1991-03-29
K910464 GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE W. L. Gore & Associates, Inc. DXZ Class II 1991-03-26
K896520 OWENS CATHETER Boston Scientific Corp LIT Class II 1991-03-25
K902185 DYNAMIC SPECTRAL PHONOCARDIOGRAPH Reeves Scientific, Inc. DQC Class I 1991-03-25
K905416 VESSEL DILATOR The R Group DRE Class II 1991-03-25
K904410 MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1991-03-25
K903848 DIAGNOSTIC INTRASCULAR CATHETER Applied Vascular Devices, Inc. DQO Class II 1991-03-25
K905489 VER-MED A10017 UNIVERSAL ELECTRODE Vermont Medical, Inc. DRX Class II 1991-03-21
K910441 FLOSCOPE MICRODOP Advance Medical Device, Inc. DPT Class II 1991-03-21
K904547 STETHOSCOPE Kimball Industries Co., Ltd. LDE Class I 1991-03-21
K910223 CPI MODEL 2215/SEAMED MODEL 3400 Seamed Corp. DTC Class II 1991-03-19
K904159 DEFIBRILLATOR ANALYZER MODEL QED-5 Bio-Tek Instruments, Inc. DRL Class II 1991-03-18
K904988 PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR Palco Laboratories, Inc. DQA Class II 1991-03-18
K905715 ACS ANGIOSCOPIC CATHETER Advanced Cardiovascular Systems, Inc. DQO Class II 1991-03-18
K904267 ZOEX ANTISHOCK TROUSERS Zoex Corp. JOW Class II 1991-03-18
K905067 PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT Pioneering Technologies, Inc. DSY Class II 1991-03-18
K905728 SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. DPT Class II 1991-03-15
K905157 FLOSCOPE VASCULAR LAB. Advance Medical Device, Inc. JOP Class II 1991-03-15
K902766 ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE Advanced Ischemia Recorders, Inc. DSH Class II 1991-03-12
K905496 WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS Meadox Medicals, Div. Boston Scientific Corp. DXZ Class II 1991-03-11
K904970 BODY COMPOSITION ANALYZER Body Composition Analog, Inc. DSB Class II 1991-03-07
K905367 E-20 RAPID CUFF INFLATOR D. E. Hokanson, Inc. DXN Class II 1991-03-06
K904785 CRI CYNOSAR CATHETER Catheter Research C/O Burditt, Bowles & Radzius DRA Class II 1991-03-06
K904748 TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 Transtracheal Systems DRG Class II 1991-03-01
K905423 CORDIS REFLEX STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1991-03-01
K903524 HORIZON 2000 ST ANALYSIS OPTION Mennen Medical, Inc. DPS Class II 1991-03-01
K904507 PILLING BRUSH VALVULOTOME Pilling Co. DWQ Class II 1991-03-01
K904606 MODEL 405 Ivy Biomedical Systems, Inc. DPS Class II 1991-03-01
K904749 TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 Transtracheal Systems DRQ Class II 1991-03-01
K902672 INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. DTB Class III 1991-03-01
K905248 NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS Advanced Technology Laboratories, Inc. DQK Class II 1991-02-28
K903026 ES-1000SP II SMART DOP Koven and Assoc., Inc. DPW Class II 1991-02-26
K904250 MODEL 4222 AMBULATORY ECG MONITOR Byrncrest Global, Inc. DXH Class II 1991-02-25
K904977 CINE/VIEW PLUS - CARDIOLOGY WORKSTATION Prism Imaging, Inc. DXK Class II 1991-02-25
K904582 QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE Meadox Surgimed, Inc. DQX Class II 1991-02-25
K904976 CINE'VIEW - STRESS ECHO & IMAGE REVIEW Prism Imaging, Inc. DXK Class II 1991-02-25
K905139 CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER Cathlab Corp. DXE Class II 1991-02-25
K910205 LP-60 LOW PRESSURE INFLATION DEVICE Devices For Vascular Intervention, Inc. MAV Class II 1991-02-25
K910112 BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR Telectronics Pacing Systems, Inc. DTD Class II 1991-02-25
K904978 SOFTWARE PROGRAM USED W/PRISM PRODUCTS Prism Imaging, Inc. DXK Class II 1991-02-25
K902628 INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT Biometric Research Institute, Inc. DXG Class II 1991-02-25
K910237 MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR Medtronic Vascular DTE Class II 1991-02-25
K904975 VISTA VIEWING STATION Prism Imaging, Inc. DXK Class II 1991-02-25
K905548 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE Mallinckrodt Medical DQX Class II 1991-02-25
K902327 EMBOLECTOMY CATHETER Clincal Instruments Corp. DXE Class II 1991-02-25
K902627 INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. Biometric Research Institute, Inc. KRB Class II 1991-02-25
K905686 SARNS TEMPERATURE PROBE AND CONNECTOR 3M Health Care, Sarns DWE Class II 1991-02-25
K902288 MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR Physio-Control Corp. LDD Class II 1991-02-25
K900677 ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER Cook, Inc. LIT Class II 1991-02-22
K905625 CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. DQO Class II 1991-02-21
K901287 INTHERM TEMPORARY OCCLUSION CATHETER Interventional Therapeutics Corp. DYG Class II 1991-02-20
K905639 TORQUE HANDLE DEVICE FOR GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 1991-02-20
K903771 HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE Hewlett-Packard Co. DXN Class II 1991-02-19
K905581 SILICONE COATED GUIDEWIRES Lake Region Mfg., Inc. DQX Class II 1991-02-19
K905249 NEW USCI 7F PTCA GUIDING CATHETER C.R. Bard, Inc. DQY Class II 1991-02-19
K905270 OCHSNER 50 VASCULAR PROSTHESIS Intervascular, Inc. DSY Class II 1991-02-15

19,212 clearances in the Cardiovascular panel. Data: openFDA.