meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
51
Latest Decision
1990-09-14

Clearances · page 138 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K903729 GOLD GATORS Lead-Lok, Inc. DRY Class II 1990-09-14
K892222 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. DSP Class II 1990-09-14
K900320 CRI CYNOSAR CATHETER Catheter Research C/O Burditt, Bowles & Radzius DRA Class II 1990-09-14
K901206 ROTABLATOR Heart Technology, Inc. MCW Class II 1990-09-14
K902368 PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH Esaote Biomedica Spa DPS Class II 1990-09-11
K901736 OXIMETRY PROBE CATHETERS Baxter Healthcare Corp DQE Class II 1990-09-11
K903704 FUKUDA DENSHI MODEL FCP-2201 MODIFICATION Fukuda Denshi USA, Inc. DSI Class II 1990-09-07
K901641 AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1990-09-05
K901253 (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 Bio Medicus, Inc. DTZ Class II 1990-09-05
K902738 ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH Labeltape Meditect, Inc. DRX Class II 1990-09-04
K903222 BIOCHEM 6100 NON-INVASIVE MONITOR Biochem International, Inc. DXN Class II 1990-09-04
K902755 .018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP Advanced Cardiovascular Systems, Inc. DQX Class II 1990-09-04
K902716 PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) Prucka Engineering, Inc. DQK Class II 1990-09-04
K903657 MODEL 610 MODIFIED First Medical Devices Corp. LDD Class II 1990-09-04
K902176 SILVER MACTRODE Marquette Electronics, Inc. DRX Class II 1990-09-04
K901657 ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND Hitachi Medical Corp. of America DXK Class II 1990-09-04
K901658 ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND Hitachi Medical Corp. of America DXK Class II 1990-09-04
K902905 COOK CORONARY GUIDING CATHETER Cook, Inc. DQY Class II 1990-09-04
K902444 CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP Intramed Laboratories, Inc. DQI Class II 1990-08-30
K902454 CATHSCANNER(R) PTA BALLOON DILATATION CATHETER Endosonics Corp. LIT Class II 1990-08-30
K901066 VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA. Pace Tech, Inc. DQA Class II 1990-08-28
K902477 WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET Medical Engineering and Development Institute DYB Class II 1990-08-24
K901392 BP50 BLOOD PRESSURE AND PULSE MONITOR Pulse Time Products, Ltd. DXN Class II 1990-08-23
K903442 ARIES TAPERSEAL(TM) SHEATH Aries Medical, Inc. DYB Class II 1990-08-23
K902192 MODEL MSC SA02-5000 PULSE OXIMETER Medical Systems Corp. DQA Class II 1990-08-23
K902652 MORTARA INSTRUMENT MODEL ELI 50 Mortara Instrument, Inc. DRT Class II 1990-08-23
K902472 MORSE DT MANIFOLD North American Instrument Corp. DRS Class II 1990-08-23
K900658 INTRODUCER, PERCUTANEOUS Novoste Puerto Rico, Inc. DYB Class II 1990-08-23
K901504 MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. Ivy Biomedical Systems, Inc. DQA Class II 1990-08-23
K902889 A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. Biotronik, GmbH & Co. DTD Class II 1990-08-23
K902758 COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC Cobe Laboratories, Inc. DQA Class II 1990-08-23
K902486 CARDIOVISTA Cardionostics, Inc. DSH Class II 1990-08-23
K900978 MANAN ARTERIAL CATHETER NEEDLE Manan Medical Products, Inc. DQY Class II 1990-08-23
K902469 BYRD DILATOR SHEATH SET - TEFLON Medical Engineering and Development Institute DRE Class II 1990-08-23
K900515 MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) Medtronic Vascular DYB Class II 1990-08-23
K901817 FUKUDA DENSHI MODEL FX-3101 Fukuda Denshi USA, Inc. DPS Class II 1990-08-23
K902355 MCR4000 & MCR4000F CARDIOTOMY RESERVOIR Medtronic Vascular DTP Class II 1990-08-23
K902453 OSCILLOMETRIC PULSE DETECTION DEVICE Thomas J. Fogarty, M.D. DRS Class II 1990-08-23
K901072 CENTRALSCOPE 12 Marquette Electronics, Inc. DXJ Class II 1990-08-23
K896497 PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON Datascope Corp. DSP Class II 1990-08-17
K900994 ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT. Dlp, Inc. DTL Class II 1990-08-15
K896738 TYPE 9293 INTERFACE PULSEOX S & W Medico Teknik DQA Class II 1990-08-14
K903360 BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION Augustine Medical, Inc. DWJ Class II 1990-08-14
K902277 BARD EXTRACORPOREAL CIRCULATION CANNULAE C.R. Bard, Inc. DWF Class II 1990-08-14
K900998 INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE Intec Medical, Inc. DQY Class II 1990-08-14
K900757 ITC ANGIOGRAPHIC CATHETER Interventional Therapeutics Corp. DQA Class II 1990-08-14
K900860 PERFUSION MONITOR Cardio Metrics, Inc. DTY Class II 1990-08-14
K901335 ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER Ge Medical Systems Information Technologies DPW Class II 1990-08-10
K902221 MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE Mallinckrodt Group, Inc. DXT Class II 1990-08-08
K900756 ITC INTRODUCER CATHETER Interventional Therapeutics Corp. DYB Class II 1990-08-08
K900645 LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING Telectronics Pacing Systems, Inc. DTB Class III 1990-08-08
K902207 ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1990-08-08
K902088 MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND Hewlett-Packard Co. DPW Class II 1990-08-08
K896824 BIOTRONIK'S PS-ENDOCARDIAL LEADS Biotronik, GmbH & Co. DTB Class III 1990-08-08
K901252 HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS Hewlett-Packard Co. DXQ Class II 1990-07-31
K901247 TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES Intec Medical, Inc. DYG Class II 1990-07-31
K900682 PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE Contour Electrodes, Inc. DRY Class II 1990-07-31
K902152 MOVABLE CORE GUIDEWIRE Guidewire Technologies, Inc. DQX Class II 1990-07-31
K896985 ZAP-GUARD Guardian Angel Products, Inc. DRL Class II 1990-07-31
K900459 APPLICARD (EKG) Medi-Globe Corp. DRY Class II 1990-07-31
K900207 EPICARDIA 4000 Medicomp, Inc. DST Class II 1990-07-31
K896807 SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM Gish Biomedical, Inc. DTR Class II 1990-07-31
K902407 NF-50-E DISPOSABLE ECG ELECTRODE Medicotest, Inc. DRX Class II 1990-07-31
K902153 TEFLON COATED GUIDEWIRE Guidewire Technologies, Inc. DQX Class II 1990-07-31
K902251 SUBCLAVIAN INTRODUCER SET Infusaid Corp. DYB Class II 1990-07-31
K902254 ESCORT MODEL 400T TELEMETRY ECG MONITOR Medical Data Electronics DXH Class II 1990-07-27
K902042 EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER Em-Scan, Inc. DSB Class II 1990-07-26
K902679 MODELS 4201, 4231 & 4235 EXTENSION CABLES Pace Medical DTE Class II 1990-07-19
K901382 ISOFLO(TM) HIGH PRESSURE INJECTION LINES Healthdyne Cardiovascular, Inc. DXT Class II 1990-07-19
K900365 PAG MICROPROCESSOR-CONTROLLED MODULE Life Sciences Manufacturing, Inc. DQC Class I 1990-07-18
K902590 THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT Marquette Electronics, Inc. LDD Class II 1990-07-18
K901555 MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE Medtronic Vascular DRX Class II 1990-07-18
K900664 DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES Sterimed, Inc. DRC Class II 1990-07-18
K896500 CWD/PPG MODULE Life Sciences Manufacturing, Inc. JOM Class II 1990-07-18
K902080 RED DOT 2269 INFANT MONITORING ELECTRODE 3M Company DRX Class II 1990-07-18
K900451 VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE Pace Tech, Inc. DRT Class II 1990-07-18
K901819 MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) Hewlett-Packard Co. DQA Class II 1990-07-18
K900220 TRANS-PACE 100 Synchromed Corp. DTE Class II 1990-07-17
K902147 ENDOCARDIAL SCREW-IN LEAD MODEL 1028T Pacesetter Systems DTB Class III 1990-07-17
K900247 CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM Colin Medical Instruments Corp. DXN Class II 1990-07-17
K900311 ARTERIAL EMBOLECTOMY CATHETER Impra, Inc. DXE Class II 1990-07-17
K900460 MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER Novoste Corp. DQO Class II 1990-07-17
K901947 CARDISUNY 501AB Graham-Field, Inc. DPS Class II 1990-07-17
K896742 FOCUS J81F, J83F, J41F, J43F PACING LEADS Ela Medical, Inc. DTB Class III 1990-07-17
K901889 FUKUDA DENSHI MODEL HJ-310 Fukuda Denshi USA, Inc. DXN Class II 1990-07-17
K900350 LEOCOR CORFLO(TM) PUMP Leocor, Inc. DXK Class II 1990-07-17
K901948 CARDISUNY 501BIII Graham-Field, Inc. DPS Class II 1990-07-17
K897124 SMALL VESSEL BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1990-07-17
K900540 TRAM PATIENT MONITOR Marquette Electronics, Inc. DSI Class II 1990-07-17
K901733 MODIFIED FLOCATH PULMONARY ARTERY CATHETER Cardio Metrics, Inc. DPW Class II 1990-07-16
K902608 CARDIOMATIC MODEL MSC-1001 Medical Systems Corp. DRT Class II 1990-07-13
K902198 SARNS DELPHIN BASE ADAPTER WITH BATTERY 3M Company KFM Class II 1990-07-13
K900541 LIFE-TEL CELLULAR TRANSCEIVER Racom, Inc. DXH Class II 1990-07-13
K901562 CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. DXK Class II 1990-07-09
K901628 APPLIED VASCULAR DEVICES 6MM TRACTION CLIP Applied Vascular Devices, Inc. DXC Class II 1990-07-06
K901625 FOGARTY ARTERIAL EMBOLECTOMY II CATHETER Baxter Healthcare Corp DXE Class II 1990-07-06
K901601 HOLLOW MOTOR DRIVE UNIT Devices For Vascular Intervention, Inc. LIT Class II 1990-07-06
K902228 MODIFIED EPICARDIAL ARRAY C.R. Bard, Inc. DRF Class II 1990-07-06
K902492 CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S Datex Division Instrumentarium Corp. DRI Class I 1990-07-06
K902493 CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR Datex Division Instrumentarium Corp. DRI Class I 1990-07-06

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