meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1990-12-06

Clearances · page 137 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K903931 GORE-TEX(R) STRETCH VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1990-12-06
K903417 VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH Vas-Cath, Inc. LIT Class II 1990-12-05
K903722 MICROMED QRS CARD Nasiff Assoc., Inc. DPS Class II 1990-12-05
K904462 MODEL #210 STEALTH DEFIB PADS Cardiotronics, Inc. LDD Class II 1990-12-03
K904394 INFLATION/DEFLATION DEVICE Boston Scientific Corp MAV Class II 1990-12-03
K900560 ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE Acuson Corp. DQC Class I 1990-12-03
K904212 HIGH-PRESSURE CONNECTOR TUBE Mallinckrodt Medical DXT Class II 1990-12-03
K903964 OCHSNER 50 BIFURCATION Intervascular, Inc. DSY Class II 1990-12-03
K903018 MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002 Medtronic Andover Medical, Inc. LDD Class II 1990-12-03
K902845 GENTLE HEADER Enhanced Perfusion Systems, Inc. DWE Class II 1990-12-03
K902475 CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS Cardio-Pak DXT Class II 1990-12-03
K902587 SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH Schneider Intl., Ltd. DQY Class II 1990-12-03
K896437 KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM Kontron Instruments, Inc. DPT Class II 1990-12-03
K901502 AMPLATZ GOOSE-NECK SNARE Microvena Corp. DXE Class II 1990-12-03
K904608 PERCUTANEOUS INTRODUCER TRAY Thomas Medical Products, Inc. DQY Class II 1990-12-03
K902317 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH. Mallinckrodt Medical LIT Class II 1990-12-03
K902695 DISPOSABLE INFLATION GAUGE Cook Urological, Inc. MAV Class II 1990-12-03
K902367 OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER Vas-Cath, Inc. LIT Class II 1990-12-03
K902612 CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT Cordis Corp. DQX Class II 1990-12-03
K900001 COROMETRICS MODEL 556 NEONATAL MONITOR Ge Medical Systems Information Technologies DQA Class II 1990-11-29
K903923 USCI(R) SILK (TM) GUIDE WIRE C.R. Bard, Inc. DQX Class II 1990-11-21
K903437 DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER Keller Medical Specialties Products, Inc. DRO Class II 1990-11-16
K903839 INTERSPEC APOGEE Interspec, Inc. DXK Class II 1990-11-16
K901514 XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. Ppg Industries, Inc. DSK Class II 1990-11-16
K903930 DATASCOPE PERCOR STAT DL 10.5 FR 50CC Datascope Corp. DSP Class II 1990-11-16
K903710 WASHINGTON CARDIAC MONITOR Washington Biolab, Inc. DXK Class II 1990-11-09
K901659 TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS Boston Scientific Corp DTK Class II 1990-11-08
K903221 LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN Telectronics Pacing Systems, Inc. DTB Class III 1990-11-08
K903625 DOPPLER NEEDLE AND FLOW MONITOR Peripheral Systems Group DPW Class II 1990-11-07
K903582 ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. Catheter Sciences Co. LIT Class II 1990-11-06
K903555 ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC. Jason Marketing Co. DRX Class II 1990-11-05
K901015 WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC Wright Medical Corp. DPW Class II 1990-11-05
K902654 CDI (TM) SYSTEM 100 MONITORING SYSTEM 3M Health Care, Ltd. DTY Class II 1990-11-05
K900720 MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED) Mortara Instrument, Inc. DSI Class II 1990-11-05
K902771 ARTERIAL BLOOD SAMPLING KIT Medex, Inc. DQO Class II 1990-11-05
K902741 VASCUMED EZ Y-CONNECTOR Vascumed Systems DTL Class II 1990-11-01
K903410 BIO-MEDICUS CANNULA INTRODUCER Bio Medicus, Inc. DYB Class II 1990-10-31
K903918 MODEL 1850 ELECTRODE Medtronic Vascular DRX Class II 1990-10-31
K904185 SENSATRACE Ludlow Corp., Technical Papers Division DRX Class II 1990-10-31
K902478 LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR Physio-Control Corp. LDD Class II 1990-10-31
K900094 PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1990-10-31
K903330 MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER Mallinckrodt Medical DQY Class II 1990-10-23
K903919 IMPLANTABLE PULSE DEVICES Medtronic Vascular DXY Class III 1990-10-23
K903523 HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE Hewlett-Packard Co. DQA Class II 1990-10-23
K897173 SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR Advanced Medical Instruments, Inc. DXN Class II 1990-10-23
K902756 TROPI-COOL Seabrook Medical Systems, Inc. DWJ Class II 1990-10-22
K903331 ROZINN 151 Rozinn Electronics, Inc. DSH Class II 1990-10-22
K902730 SPO2 OPTION Protocol Systems, Inc. DQA Class II 1990-10-22
K901592 MODEL MD-5 DOPPLER D. E. Hokanson, Inc. DXK Class II 1990-10-22
K904414 DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS Datascope Corp. DSP Class II 1990-10-22
K903530 PERCUTANEOUS INTRODUCERS Davol, Inc. DYB Class II 1990-10-22
K903436 SARNS MEMBRANE OXGENATOR PART NUMBER 9443 3M Health Care, Sarns DTZ Class II 1990-10-19
K901627 ARTERIAL EMBOLECTOMY CATHETER Applied Vascular Devices, Inc. DXE Class II 1990-10-19
K900710 INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER Intec Medical, Inc. KRB Class II 1990-10-19
K903893 DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL Datascope Corp. DSP Class II 1990-10-19
K903217 TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER Intec Medical, Inc. DQY Class II 1990-10-19
K903867 DATASCOPE PERCOR STAT DL 10.5 FR 40CC Datascope Corp. DSP Class II 1990-10-19
K903702 MODEL 90421 FLEXPORT INTERFACE Spacelabs, Inc. DQA Class II 1990-10-19
K904018 DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL Datascope Corp. DSP Class II 1990-10-19
K903769 PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON Datascope Corp. DSP Class II 1990-10-19
K903379 PYMAH PRE-GAGED BALANCED TEMPA-KUFF Pymah Corp. DXQ Class II 1990-10-19
K903892 DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL Datascope Corp. DSP Class II 1990-10-19
K903216 THE GUIDER CORONARY GUIDING CATHETER Intec Medical, Inc. DQY Class II 1990-10-19
K903494 MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP Life-Tech Intl., Inc. DXT Class II 1990-10-17
K903928 LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP Biotronik, GmbH & Co. DTB Class III 1990-10-16
K900607 MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 Cardiodata Corp. DSI Class II 1990-10-16
K902518 LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE Pall Biomedical Products Co. DTM Class II 1990-10-16
K903840 GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY Intec Medical, Inc. DYB Class II 1990-10-16
K903929 LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP Biotronik, GmbH & Co. DTB Class III 1990-10-16
K902932 DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL Datascope Corp. DYB Class II 1990-10-16
K902143 FOGARTY VESSEL CALIBRATOR Baxter Healthcare Corp DWP Class II 1990-10-16
K897106 MEDI-TECH DILATATION CATHETERS ULTRA THIN II Boston Scientific Corp LIT Class II 1990-10-16
K903927 LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP Biotronik, GmbH & Co. DTB Class III 1990-10-16
K902342 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491 Medtronic Vascular LDF Class II 1990-10-16
K903880 FRANZ(TM) STEERABLE COMBINATION CATHETER Ep Technologies, Inc. DRF Class II 1990-10-12
K901780 RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE Medtronic Vascular DSA Class II 1990-10-09
K901235 GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER Boston Scientific Corp DTK Class II 1990-10-09
K903736 DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL Datascope Corp. DSP Class II 1990-10-09
K903960 MODEL 9444 TELETRACE II ECG MONITORING SYSTEM Medtronic Vascular DXH Class II 1990-10-09
K903633 ADVANCE LASER FLOWMETER, ALF 21 Transonic Systems, Inc. DPW Class II 1990-10-09
K903503 SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 Scimed MAV Class II 1990-10-09
K903495 LIQUID DETECTOR Life-Tech Intl., Inc. DXT Class II 1990-10-05
K902943 RSI FEMORAL GUIDING CATHETER Retroperfusion Systems, Inc. DQO Class II 1990-10-03
K896017 THE OPHTHIMUS SYSTEM Hightech Vision DQK Class II 1990-10-02
K902953 SOFTOUCH GUIDING CATHETER Mallinckrodt Medical DQO Class II 1990-09-28
K902429 MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE Laerdal Mfg. Corp. LDD Class II 1990-09-27
K901899 ROADRUNNER WIRE GUIDE Cook, Inc. DQX Class II 1990-09-27
K903606 GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER North American Instrument Corp. LIT Class II 1990-09-27
K902856 BARD FILTERED CARDIOTOMY RESERVOIR C.R. Bard, Inc. DTP Class II 1990-09-27
K903158 SITERITE NEEDLE GUIDE Dymax Corp DQY Class II 1990-09-27
K902779 MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA S & W Medico Teknik DQA Class II 1990-09-27
K902394 RESUBMITTED MULTIORGAN PERFUSION CANNULA Fresenius USA, Inc. DWF Class II 1990-09-27
K903390 MEDRAD MARK V-PLUS INJECTOR Medrad, Inc. DXT Class II 1990-09-26
K902002 MODELS 5069/5071 MYOCARDIAL PACING LEADS Medtronic Vascular DTB Class III 1990-09-26
K902091 SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER Schneider Intl., Ltd. LIT Class II 1990-09-26
K903906 PERCUTANEOUS CATHETER INTRODUCER KIT Intec Medical, Inc. DYB Class II 1990-09-26
K902275 PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. DYB Class II 1990-09-26
K902057 PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG Datascope Corp. DSP Class II 1990-09-25
K903414 TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN Echo Ultrasound DXK Class II 1990-09-19
K903081 NEOS (TM) 02 B PULSE GENERATOR Biotronik, GmbH & Co. DXY Class III 1990-09-14

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