meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
1987-03-04

Clearances · page 154 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K864613 502 OXYGEN SATURATION MONITOR Criticare Systems, Inc. DQA Class II 1987-03-04
K870323 MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER Pace Medical DTE Class II 1987-03-03
K870163 BIOCHEM MICROSPAN 1040 OXIMETER Biochem International, Inc. DQA Class II 1987-03-03
K864989 ETP 180A NON-INVASIVE EXTERNAL PACEMAKER Medac, Inc. DRO Class II 1987-03-03
K864986 ETP 300 NON-INVASIVE EXTERNAL PACEMAKER Medac, Inc. DRO Class II 1987-03-03
K870562 DAIG PACEMAKER LEAD ADAPTOR Daig Corp. DTD Class II 1987-03-03
K865079 ASPIRATING NEEDLE, CATALOG CODE #12006 Dlp, Inc. DWF Class II 1987-03-03
K870034 MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD Oscor Medical Corp. DTB Class III 1987-03-03
K864401 PLURIMUS CARDIAC EVALUATION SYSTEM Vivix Corp. DSI Class II 1987-03-03
K864987 DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE Medac, Inc. DRO Class II 1987-03-03
K863342 SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER Angiomedics, Inc. DWF Class II 1987-03-03
K864988 ETP 180E NON-INVASIVE EXTERNAL PACEMAKER Medac, Inc. DRO Class II 1987-03-03
K864259 MODIFIED LASERFLO BLOOD PERFUSION MONITOR Tsi, Inc. DPW Class II 1987-02-20
K864580 MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM) Mortara Instrument, Inc. DPS Class II 1987-02-20
K870073 MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB Clinical Connections, Inc. DTL Class II 1987-02-20
K870186 ENDOMYOCARDIAL BIOPSY DEVICE Mansfield Scientific, Inc. DWZ Class II 1987-02-20
K864943 NUMED BALLOON WEDGE PRESSURE CATHETER NuMED, Inc. DQO Class II 1987-02-20
K864320 SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE Cordis Corp. DRQ Class II 1987-02-20
K864978 APPLISCOPE Grandcor Medical Systems DPS Class II 1987-02-19
K865031 ELECTROCARDIOGRAPH Nihon Kohden America, Inc. DPS Class II 1987-02-19
K864895 INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER Johnson & Johnson Professionals, Inc. DTN Class II 1987-02-19
K864787 SCHNEIDER-SHILEY GUIDE WIRE Shiley, Inc. DQX Class II 1987-02-19
K864703 MODIFIED GAS-STAT(TM) MONITORING SYSTEM Cardiovascular Devices, Inc. DTY Class II 1987-02-19
K864940 NUMED BALLOON ANGIOGRAPHIC CATHETERS NuMED, Inc. DQO Class II 1987-02-19
K864700 Q700 ELECTROCARDIOGRAPH Quinton, Inc. DPS Class II 1987-02-19
K854371 MTC 6210A CARDIAC OUTPUT COMPUTER Nihon Kohden America, Inc. DXG Class II 1987-02-19
K863740 RMI FEMORAL VENOUS DRAINAGE CANNULA Research Medical, Inc. DWF Class II 1987-02-19
K864058 AMPLATZ MOVEABLE CORE GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 1987-02-19
K863891 MODIFIED STBP-680 Quinton, Inc. DXN Class II 1987-02-19
K862808 BIOMA 2000 E.B.S., Inc. DXG Class II 1987-02-19
K862261 KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263 Kontron Instruments, Inc. DXG Class II 1987-02-19
K864890 STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP Shiley, Inc. KRI Class I 1987-02-19
K865013 ASTRA T2, T4 AND T6 Cardiac Pacemakers, Inc. DXY Class III 1987-02-19
K864705 MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH Quinton, Inc. DYB Class II 1987-02-13
K870039 IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM Par Microsystems Corp. DSF Class I 1987-02-12
K864722 MEDI-TRACE INFANT ELECTRODE Graphic Controls Corp. DRX Class II 1987-02-10
K863898 MULTILITH 3 MODELS 1350, 3350, 1370, 3370 Ela Medical, Inc. DXY Class III 1987-02-10
K864654 COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR Colin Medical Instruments Corp. DXN Class II 1987-02-10
K863508 FRANTZ MEDICAL ELECTRODE Frantz Medical Development, Ltd. DXR Class II 1987-02-06
K863100 CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR Honeywell, Inc. DPS Class II 1987-02-03
K862383 MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER Rjl Systems, Inc. DSB Class II 1987-02-03
K864619 CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR Shiley, Inc. KRL Class II 1987-02-03
K861987 2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF Ohmeda Medical DXN Class II 1987-02-03
K862226 DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS Pacesetter Systems DXY Class III 1987-02-03
K862859 EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND Biosound, Inc. DXK Class II 1987-02-02
K864657 ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. DXK Class II 1987-02-02
K863185 40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON Aries Medical, Inc. DSP Class II 1987-01-16
K864326 MODEL 366-13 ADAPTAID STEP DOWN ADAPTER Intermedics, Inc. DTB Class III 1987-01-16
K864000 FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 Fiberoptic Sensor Technlogies, Inc. DXO Class II 1987-01-16
K864868 MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK Hewlett-Packard Co. DRX Class II 1987-01-14
K863219 SYSTEM 90 TRANSPORT Datascope Corp. DSP Class II 1987-01-14
K863042 SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR Siemens Medical Solutions USA, Inc. DSK Class II 1987-01-14
K860036 EDP-20 PACEMAKER Biotronik Sales, Inc. DXY Class III 1987-01-12
K864009 MINGOGRAF 410 Siemens Medical Solutions USA, Inc. DPS Class II 1987-01-12
K863918 MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT. Marquest Medical Products, Inc. DQA Class II 1987-01-07
K864738 MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP Intermedics, Inc. DTB Class III 1987-01-06
K863917 CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. Cardio-Vascular Innovations, Inc. DYB Class II 1987-01-06
K863914 MODIFICATION TO DYNASCOPE SERIES MONITORS Fukuda Denshi USA, Inc. DPS Class II 1987-01-06
K863535 LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. Computerized Medical Systems, Inc. DPS Class II 1987-01-06
K864330 SHEAR FORCE GAUGE American Edwards Laboratories DXE Class II 1987-01-06
K864062 PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED) Ideas For Medicine, Inc. DXE Class II 1987-01-06
K863153 MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH Ocg Technology, Inc. DXG Class II 1987-01-06
K863916 CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM Cardio-Vascular Innovations, Inc. DQY Class II 1987-01-06
K864601 CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD Cardiac Control Systems, Inc. DTB Class III 1987-01-06
K863369 MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES Tdk Corp. DRX Class II 1987-01-06
K864153 PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 Pace Medical DTB Class III 1987-01-06
K862051 MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1987-01-06
K864352 MODIFIED PEEL-AWAY INTRODUCER SET LINE Quinton, Inc. DYB Class II 1987-01-06
K864640 ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD Cordis Corp. DTB Class III 1987-01-06
K863536 MEDTRONIC MODEL 5013 Medtronic Vascular DTB Class III 1987-01-06
K863904 DISPOSABLE ECG MONITORING ELECTRODE Clinical Data, Inc. DRX Class II 1987-01-06
K864503 MODIFIED RLV-2100 B American Omni Medical, Inc. DWD Class II 1987-01-06
K863855 ACCUSAT Datascope Corp. DQA Class II 1987-01-06
K861241 ANGIOTOPO CATHETER Houston Biomedical, Inc. DQO Class II 1987-01-06
K864856 MODEL 5866-24 PACEMAKER LEAD ADAPTOR Medtronic Vascular DTB Class III 1987-01-06
K863684 URESIL SUBCLAVIAN CATHETER Uresil Corp. DQY Class II 1987-01-06
K853952 METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME Metriflow, Inc. DPW Class II 1987-01-05
K861205 1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER Valhalla Scientific DSB Class II 1987-01-05
K864235 BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600 C.R. Bard, Inc. DTZ Class II 1987-01-02
K864262 ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING Johnson & Johnson Professionals, Inc. DTM Class II 1987-01-02
K863308 2200I PHYSIOLOGICAL MONITOR Datascope Corp. DXG Class II 1987-01-02
K864007 EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER Uresil Corp. DXE Class II 1987-01-02
K862724 VEIN VALVE CUTTER American Edwards Laboratories DQY Class II 1987-01-02
K862459 MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE Medtronic Vascular DXY Class III 1987-01-02
K863466 M700 STRESS MONITOR Kone Instruments, Inc. DRT Class II 1986-12-22
K863494 NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 Advantage Medical Systems, Inc. DRT Class II 1986-12-22
K862668 HEALTHPHONE(TM) Carelink DXH Class II 1986-12-22
K862812 NELLCOR MVP, MODEL N-1000 Nellcor, Inc. DQA Class II 1986-12-22
K863965 KENZ-ECG 102 Compumed, Inc. DXK Class II 1986-12-22
K861856 NBP 488, TPR 488 Siemens Medical Solutions USA, Inc. DXN Class II 1986-12-22
K864665 MODIFIED VSM 2 VITAL SIGNS MONITOR Physio-Control Corp. DXN Class II 1986-12-11
K863960 STOCKERT-SHILEY CAPS BATTERY MODULE Shiley, Inc. DTQ Class II 1986-12-11
K863902 MODIFIED SARNS MEMBRANE OXYGENATOR 3M Health Care, Sarns DTX Class II 1986-12-11
K864666 MODIFIED LIFESTAT 200 Physio-Control Corp. DXN Class II 1986-12-11
K863878 TRIOS-M VS-1 PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1986-12-10
K863652 MODEL 456 ELECTROCARDIORECORDER RECORDER Del Mar Avionics DPS Class II 1986-12-10
K863903 SEA MED MODEL 6000 Seamed Corp. DTE Class II 1986-12-10
K864149 Q-SCAN II AND Q-SCAN III Quinton, Inc. DSI Class II 1986-12-10
K863879 NEOS-M VS-1 PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1986-12-10
K860854 CRITICALC Cygnus of South Florida, Inc. DQK Class II 1986-12-08

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