meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
1987-05-22

Clearances · page 153 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K871580 IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 Intermedics, Inc. DTB Class III 1987-05-22
K871251 CIRCAMED FULL DISCLOSURE SYSTEM Circadian, Inc. DSI Class II 1987-05-22
K871625 MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER Intermedics, Inc. DTB Class III 1987-05-21
K870357 ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY Intermedics, Inc. DTB Class III 1987-05-21
K870926 C150-P ECG CABLES Desco Industries, Inc. DPS Class II 1987-05-21
K864618 IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 Telectronics, Inc. DTB Class III 1987-05-21
K871131 SARNS 9000 HEART-LUNG CONSOLE 3M Health Care, Sarns DTQ Class II 1987-05-21
K871224 FAST-PATCH(TM) Physio-Control Corp. LDD Class II 1987-05-20
K871045 DMI AMBULATORY HOLTER MONITOR Diagnostic Medical Instruments DSH Class II 1987-05-19
K870652 MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR Medtronic Vascular DXH Class II 1987-05-14
K871011 SIMPSON PERIPHERAL ATHEROCATH(TM) Devices For Vascular Intervention, Inc. LIT Class II 1987-05-14
K871135 HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE First Medical Devices Corp. LDD Class II 1987-05-12
K864568 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER Aries Medical, Inc. DSP Class II 1987-05-12
K871136 HEARTSTART 2000, MANUAL DEFIBRILLATOR First Medical Devices Corp. LDD Class II 1987-05-12
K864567 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER Aries Medical, Inc. DSP Class II 1987-05-12
K864429 DSP100 CAROTID PHONOANGIOGRAPHY MODULE Intl. Acoustics, Inc. DQC Class I 1987-05-12
K871412 CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO Contour Electrodes, Inc. DRX Class II 1987-05-12
K864583 CARDIAC PERFORMANCE MONITOR Vascular Technology Incorporated DQK Class II 1987-05-11
K864260 APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) Grandcor Medical Systems DRX Class II 1987-05-11
K864980 3MHZ ANNULAR ARRAY Philips Ultrasound, Inc. JOP Class II 1987-05-11
K870419 IVR-SP CUSTOM ANGIOGRAPHY TRAY North Coast Medi-Tek DQO Class II 1987-05-11
K865035 RECORD KEEPING/DATA MANAGEMENT SYSTEM Critical Care Systems, Inc. DQK Class II 1987-05-11
K871377 NAMIC COURNAND STYLE INTRODUCER NEEDLE North American Instrument Corp. DRC Class II 1987-05-07
K870976 ONGUARD 1000, CATALOG #043611-000 & 043611-001 Cobe Laboratories, Inc. DTQ Class II 1987-05-06
K871333 IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL Medtronic Vascular DTB Class III 1987-05-06
K864730 INVIVO PULSE OXIMETER, MODEL 4500 Invivo Research Labs, Inc. DQA Class II 1987-05-06
K870301 MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER Medex, Inc. DRS Class II 1987-05-06
K871382 NAMIC ONE PART INTRODUCER NEEDLE North American Instrument Corp. DRC Class II 1987-05-06
K870829 SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR 3M Health Care, Sarns DTN Class II 1987-05-06
K864690 ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD Multi Biosensors, Inc. DRX Class II 1987-05-06
K865074 CORDAY CORONARY SINUS INFUSION CATHETER Retroperfusion Systems, Inc. DQY Class II 1987-05-06
K871378 NAMIC SELDINGER INTRODUCER NEEDLE North American Instrument Corp. DRC Class II 1987-05-06
K863803 VASOPULSE(TM)/MODEL 5000 Sonicaid, Inc. JOM Class II 1987-05-06
K870934 IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM Integrated Medical Systems, Inc. DXG Class II 1987-05-06
K870792 THORASTAT ATR-XXXX Gish Biomedical, Inc. DTP Class II 1987-04-28
K870067 MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20 Vygon Corp. DQY Class II 1987-04-28
K870783 BPA CARDIOVASCULAR PRESSURE AMPLIFIER Fisher Imaging Corp. DRQ Class II 1987-04-27
K870542 VASCATH VASCULAR CATHETER PLACEMENT KIT Titan Medical, Inc. DYB Class II 1987-04-27
K870325 #014160-TAB TUBING ROTATOR ADAPTOR Clinical Connections, Inc. DTL Class II 1987-04-27
K870909 PACEMAKER FUNCTION ANALYZER Paceart, Inc. KRE Class II 1987-04-27
K870075 CENTRAL VENOUS CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic DQY Class II 1987-04-27
K870538 MODEL 192 PRINTER Advanced Medical Products, Inc. DSF Class I 1987-04-23
K870537 MODEL MICRO ST AMBULATORY ECG MONITOR Advanced Medical Products, Inc. DSH Class II 1987-04-23
K871176 PACE 10 NON-INVASIVE EXTERNAL PACEMAKER Medac, Inc. DRO Class II 1987-04-23
K870049 EMT-102 CARDIAC MONITOR Evergreen Medical Technologies, Inc. DXN Class II 1987-04-22
K870142 PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR Cardio-Pace Medical, Inc. DXY Class III 1987-04-22
K871148 URESIL CAROTID ARTERY SIZERS Uresil Corp. DRE Class II 1987-04-22
K871140 ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER Aries Medical, Inc. DYB Class II 1987-04-22
K870527 CARDIOTEAM Cardiac Network, Inc. DXH Class II 1987-04-20
K865101 SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM Spectramed, Inc. DXG Class II 1987-04-20
K871132 PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS Deltec Systems, Inc. DYB Class II 1987-04-20
K870622 HEART*AID 1000 Cardiac Resucitator Corp. MKJ Class III 1987-04-10
K870873 MD MONITORING/DIAGNOSTIC ELECTRODE Lectec Corp. DRX Class II 1987-04-10
K861505 HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER American Medical Equipment, Inc. DXG Class II 1987-04-10
K870948 MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1987-04-10
K870119 FIBRE OPTIC STRIP CHART RECORDER Apex Imaging Corp. DSF Class I 1987-04-10
K864118 MEDI-TECH SELECTIVE TORQUE CATHETER Medi-Tech, Inc. DQY Class II 1987-04-09
K870729 TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER Medi-Tech, Inc. DTK Class II 1987-04-09
K870907 INTRODUCER, PERCUTANEOUS Med Fusion Systems, Inc. DYB Class II 1987-04-09
K864504 Q5000 STRESS TEST MONITOR Quinton, Inc. DPS Class II 1987-04-09
K870675 ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY Quinton, Inc. DQY Class II 1987-04-09
K864818 ACKRAD TDI SET Ackrad Laboratories KRB Class II 1987-04-09
K870880 EK10 ELECTROCARDIOGRAPH Burdick Corp. DPS Class II 1987-04-09
K870728 TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 A&D Engineering, Inc. DRQ Class II 1987-03-27
K870664 GUIDE WIRE Datascope Corp. DQX Class II 1987-03-25
K871025 FUKUDA DENSHI MODEL FCP-15 Fukuda Denshi USA, Inc. DSI Class II 1987-03-24
K862427 MODIFIED DRAGER SPHYGMOMED Draeger Medical, Inc. DXN Class II 1987-03-23
K864293 HEART TRACK Cardio Telemetric Systems, Inc. DXH Class II 1987-03-23
K870554 CASSETTE TAPE REPLAY SYSTEM Research Instrumentation Associates, Inc. DSH Class II 1987-03-23
K870834 TDK ECG ELECTRODE MEL-10 Tdk Corp. DRX Class II 1987-03-23
K870826 ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. Shiley, Inc. DQR Class II 1987-03-23
K870825 NEW MODEL STYLES FOR AORTIC ARCH CANNULA Shiley, Inc. DQR Class II 1987-03-23
K864465 CARDIOVIT AT-6 Schiller Corp. DPS Class II 1987-03-20
K864090 SHELF LIFE CHANGE OF STERILE DEVICES Utah Medical Products, Inc. DRS Class II 1987-03-20
K864704 CARDIAN III CR6A Cardiac Recorders, Ltd. DPS Class II 1987-03-20
K870621 SATLITE/PB251 PULSE OXIMETER Datex Division Instrumentarium Corp. DQA Class II 1987-03-20
K864318 THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM The Buddy Systems, Inc. DXN Class II 1987-03-20
K864748 PM-8 HEART RATE MONITOR Pulse Time Products, Ltd. DRT Class II 1987-03-20
K870610 RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE Telectronics, Inc. DTB Class III 1987-03-20
K864316 TARGET THERAPEUTICS TAPER GUIDE WIRE Target Therapeutics DQX Class II 1987-03-20
K870824 ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 Pacesetter Systems DTB Class III 1987-03-20
K870374 PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK Daig Corp. DYB Class II 1987-03-18
K863833 BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010 Body Watch, Inc. DSB Class II 1987-03-17
K864843 HORIZON 1100 CARDIAC MONITOR Mennen Medical, Inc. DPS Class II 1987-03-16
K870109 RMI VENOUS DRAINAGE CANNULA Research Medical, Inc. DWF Class II 1987-03-16
K870507 GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA Research Medical, Inc. DWF Class II 1987-03-16
K870189 ARIES TAPERED SHEATH Aries Medical, Inc. DYB Class II 1987-03-16
K864586 S&W ELECTRODE TYPES 888, 844, 988 AND 944 S & W Medico Teknik DRX Class II 1987-03-13
K865011 PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER Labeltape Meditect, Inc. DRX Class II 1987-03-13
K864737 NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340 Siemens Medical Solutions USA, Inc. DXN Class II 1987-03-12
K864279 SPACELABS MODEL 90419 PULSE OXIMETER MODULE Spacelabs, Inc. DQA Class II 1987-03-11
K870380 MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03 Hewlett-Packard Co. DPS Class II 1987-03-11
K863674 TRACETS 2000/ELECTRODES Lectec Corp. DRX Class II 1987-03-11
K853194 ERA-20 Biotronik Sales, Inc. DTE Class II 1987-03-11
K861543 CARDIOMAX-II Columbus Instruments Intl. Corp. DXG Class II 1987-03-10
K865030 CARDIOFAX-V ECG-8240A Nihon Kohden America, Inc. DSI Class II 1987-03-10
K864985 DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE Medac, Inc. DRO Class II 1987-03-10
K865032 CARDIOFAX-V ECG-834OA Nihon Kohden America, Inc. DSI Class II 1987-03-10
K864889 OMNI-TRAK Invivo Research Labs, Inc. DSB Class II 1987-03-06
K864507 V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 Spectramed, Inc. LDF Class II 1987-03-06

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