meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
1985-01-24

Clearances · page 165 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K844811 PACE AID MODEL 53 Cardiac Resucitator Corp. DRO Class II 1985-01-24
K844584 GORE-TEX TUNNELER W. L. Gore & Associates, Inc. DWS Class I 1985-01-24
K842705 MX2 ELECTRONIC STETHOSCOPE Medmax, Inc. DQD Class II 1985-01-23
K843969 MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER Gould, Inc. DXO Class II 1985-01-23
K844744 CARDIO IV/GXT STRESS TESTING SYSTEM Intl. Medical, Inc. DPS Class II 1985-01-23
K844650 DR-2C General Devices DXJ Class II 1985-01-22
K850070 HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 Healthcheck Corp. DXN Class II 1985-01-22
K842031 TRANSVENOUS TINED VENTRICULAR/ATRIAL Medtronic Vascular DTB Class III 1985-01-18
K842032 MODELS 4012/4512 TRANSVENOUS TINED- Medtronic Vascular DTB Class III 1985-01-18
K842065 EPICARDIAL, UNIPOLAR LEAD 4951 Medtronic Vascular DTD Class II 1985-01-18
K844103 CARDIOPAC DEFIBRILLATOR 444 Birtcher Corp. LDD Class II 1985-01-18
K842236 PATIENT MONITOR 78354A Hewlett-Packard Co. DRT Class II 1985-01-18
K842145 TRANSVENOUS TINED VENTRICULAR LEAD Medtronic Vascular DTD Class II 1985-01-18
K844911 ARRHYTHMIA CENTRAL-OGP-7201 Nihon Kohden America, Inc. DRT Class II 1985-01-18
K843137 BP 5000 Tech Vend Marketing DXN Class II 1985-01-16
K842105 RIGHT VENTRICULAR EJECTION FRACTION- American Edwards Laboratories DXG Class II 1985-01-15
K844632 INFANT LIMB ELECTRODE Sentry Medical Products, Inc. DRX Class II 1985-01-14
K844229 VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX Gish Biomedical, Inc. DTN Class II 1985-01-14
K841401 SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER American Edwards Laboratories DXG Class II 1985-01-14
K843232 SHILEY HARDSHELL VENOUS RESERVOIR W/INT Shiley, Inc. DTN Class II 1985-01-14
K843290 NUMED BALLOON PACING CATHETER NuMED, Inc. LDF Class II 1985-01-14
K844366 CARDIOTOMY RESERVOIR BCR-2000 American Bentley DTN Class II 1985-01-14
K844447 M/D4 W/CHARGER (CARDIOPAC 3M11) Datascope Corp. LDD Class II 1985-01-14
K844367 CARDIOTOMY RESERVOIR W/FILTER BCR-2500 American Bentley DTN Class II 1985-01-14
K844977 HOLTER CURA-LITE RECORDER Cardionostics, Inc. DSH Class II 1985-01-14
K844959 MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN Medtronic Vascular DTB Class III 1985-01-10
K844334 VIVALITH II 301 PULSE GENERATOR Pacesetter Systems DXY Class III 1985-01-10
K823844 HORIZON ECG SYSTEM Beckman Instruments, Inc. DSI Class II 1985-01-10
K844376 MODEL 78210A TELEMETRY TRANSMITTER Hewlett-Packard Co. DRG Class II 1985-01-10
K844470 FUKUDA DENSHI MODEL FCP-220 Brentwood Instruments, Inc. DPS Class II 1985-01-10
K842193 MULTILITH PULSE GENERATORS, 1141 & 2141 Ela Medical, Inc. DXY Class III 1985-01-10
K843703 PERMATHANE 865 & 867 UNIPOLAR POLYURETH Pacesetter Systems DTD Class II 1985-01-08
K843707 MEDTRONIC 6957J Medtronic Vascular DTB Class III 1985-01-08
K842813 HEPARIN COATED ARTERIAL BLOOD FILTERS American Bentley DTM Class II 1985-01-08
K843956 SCIMED II MEMBRANE OXYGENATOR SYSTEM Scimed Life Systems, Inc. DTZ Class II 1985-01-08
K833561 LIGHT REFLECTION RHEOGRAPHY Instru-Med, Inc. JOM Class II 1985-01-08
K844391 NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS Ams Medical, Inc. DXH Class II 1985-01-07
K844161 PTCA GUIDING CATHER Cordis Corp. DQO Class II 1985-01-02
K844345 CONTOUR ELECTRODE Heuristic Medical Systems, Inc. DRX Class II 1985-01-02
K844335 ELECTROCARDIOGRAPH ELECTRODE Meditect DRX Class II 1985-01-02
K841926 HYDROGLIDE SPRING GUIDE WIRES Argon Medical Corp. DQX Class II 1985-01-02
K844805 ELECATH GALLAGHER MAPPING CATHETER Electro-Catheter Corp. DRF Class II 1985-01-02
K844752 TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA Mansfield Scientific, Inc. DTB Class III 1985-01-02
K833644 FILTER PURGE LINE EC-FPL SERIES Gish Biomedical, Inc. DTL Class II 1984-12-29
K843798 MEADOX SURGIMED A/S CATHETER SHEATH SYS Meadox Surgimed, Inc. DYB Class II 1984-12-27
K844003 ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH Electro-Catheter Corp. LDF Class II 1984-12-27
K843376 ECG PATIENT MONITOR Rigel Medical Electronics, Inc. DRT Class II 1984-12-27
K844137 STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN Shiley, Inc. DWF Class II 1984-12-27
K843802 STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR Shiley, Inc. DTW Class II 1984-12-27
K844138 STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI Shiley, Inc. DWF Class II 1984-12-27
K811259 CORDIS ENCOR ATRIAL LEAD Cordis Corp. DTB Class III 1984-12-27
K842373 VENOUS RESERVOIR-BMR-1500-HARD SHELL American Bentley DTP Class II 1984-12-27
K843706 MEDTRONIC 6957 Medtronic Vascular DTB Class III 1984-12-27
K843983 MYOCARDIAL INSULATOR Norton Texas Medical Products DTR Class II 1984-12-27
K844256 NELLCOR PULSE OXIMETER N-10 Nellcor, Inc. DQA Class II 1984-12-27
K844140 STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH Shiley, Inc. DWF Class II 1984-12-27
K844100 CANMED 101 Medtronic Vascular DRX Class II 1984-12-27
K844139 STOCKERT-SHILEY INTRACARDIAC SUCKERS Shiley, Inc. DWF Class II 1984-12-27
K844099 CANMED 102 Medtronic Vascular DRX Class II 1984-12-27
K843165 ULTRASOUND 72X & ANNULAR ARRAY SCAN- Advanced Technology Laboratories, Inc. JOP Class II 1984-12-20
K843131 ACCESS & 72X ULTRASOUND SCANHEAD UM4 Advanced Technology Laboratories, Inc. JOP Class II 1984-12-20
K842339 COMPUSTRESS STRESS TESTING SYS Intl. Medical, Inc. DQK Class II 1984-12-19
K843547 PACE *AID MODEL 52 Cardiac Resucitator Corp. DRO Class II 1984-12-17
K841654 DEL MAR AVIONICS 509 NEUROCORDER AMBUL Del Mar Avionics DSH Class II 1984-12-11
K842582 CARE 5000 CENTRAL MONITOR MS5220 ETC. Care Monitoring Systems DRT Class II 1984-12-11
K842370 PAGE-WRITER INTERPRETIVE CARDIOGRAPH Hewlett-Packard Co. DXH Class II 1984-12-07
K843129 SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8 Advanced Technology Laboratories, Inc. JOP Class II 1984-12-06
K843130 SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 Advanced Technology Laboratories, Inc. JOP Class II 1984-12-06
K844348 DYNASCOPE MONITOR DS-800 Fukuda Denshi USA, Inc. DRT Class II 1984-12-04
K841232 PULSE GENERATOR 696, 696B & 696L Siemens Elema AB DXY Class III 1984-12-03
K841230 PULSE GENERATOR 686, 686B 686L Siemens Elema AB DXY Class III 1984-12-03
K841225 PULSE GENERATOR 689, 689B & 689L Siemens Elema AB DXY Class III 1984-12-03
K843012 WIREGUIDE OR GUIDEWIRE Medi-Tech, Inc. DQX Class II 1984-11-29
K843955 EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR Extracorporeal Medical Specialities, Inc. DTZ Class II 1984-11-29
K842220 MULTILITH 2 PULSE GENERATOR 1141 & 2141 Ela Medical, Inc. DXY Class III 1984-11-29
K841227 BIPOLAR ENDOCARDIAL LEAD 406L Siemens Elema AB DTD Class II 1984-11-27
K842706 SCATAID Sc Applied Technology, Inc. DXG Class II 1984-11-27
K843880 LOW PROFILE STEERABLE BALLOON DILATION Advanced Cardiovascular Systems, Inc. LIT Class II 1984-11-27
K840899 SERVOMED ARRHYCOMP CENTRAL MONITOR SYS Litton Medical Electronics DSI Class II 1984-11-20
K843934 MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT Future Impex Corp. DPS Class II 1984-11-20
K843412 FLOW DIRECTED THERMODILUTION CATH W/VEN Andover Medical, Inc. KRB Class II 1984-11-20
K843410 FLOW-DIRECTED PEDIATRIC THERMODIL- CATH Andover Medical, Inc. KRB Class II 1984-11-20
K840439 RECOMED CARDIAC OUTPUT METER 236067- Litton Medical Electronics DXG Class II 1984-11-20
K844022 ELECATH VENTRICULAR PACING THERMAL DILUTION CATH Electro-Catheter Corp. DXG Class II 1984-11-20
K843358 HEART-AID MODEL 80 Cardiac Resucitator Corp. DRO Class II 1984-11-19
K842715 DOCUMENTOR Life Technology DSI Class II 1984-11-19
K841235 MEDO MEDOMER MBF-100 II Medo U.S.A., Inc. JOW Class II 1984-11-19
K842123 PERSONAL CL SINGLE-CHANNEL ELECTROCAR Parexel Intl. Corp. DSI Class II 1984-11-16
K844045 ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT Advanced Cardiovascular Systems, Inc. DXT Class II 1984-11-13
K843118 CANNULA INTRODUCER Cardiovascular Research, Inc. DYB Class II 1984-11-13
K841246 PORTABLE NURSING UNIT TERMINAL Ncr Corp. DXN Class II 1984-11-08
K833763 PERICARDIAL PATCH American Edwards Laboratories DXZ Class II 1984-11-01
K840358 IMPEDANCE/8200 MONITOR-MODEL 8300 Aequitron Medical, Inc. KRC Class II 1984-10-30
K840932 MUSE-DP Marquette Electronics, Inc. DXN Class II 1984-10-30
K840523 SERVOMED PULSE AMPLIFIER MODULE-206- Litton Medical Electronics DRT Class II 1984-10-29
K841472 CARDIORHYTHM 2000 Biogenix, Inc. DSH Class II 1984-10-29
K833689 DIASCOPE 2 S & W Medico Teknik DRT Class II 1984-10-26
K840524 SERVOMED BASIC BEDSIDE UNIT SMV 110TP Litton Medical Electronics DRT Class II 1984-10-26
K840587 INSTANT REPLAY Instromedix, Inc. DXH Class II 1984-10-26
K832833 PERSONAL DEFIBRILLATOR Physio-Control, Inc. LDD Class II 1984-10-26

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