meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
1986-12-08

Clearances · page 155 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K863584 EM II STRESS TEST ELECTRODE Electromed Intl., Ltd. DRX Class II 1986-12-08
K863540 EM II DISPOSABLE ELECTRODE Electromed Intl., Ltd. DRX Class II 1986-12-08
K864098 TELECTRONICS SREW-IN/SLIM LINE PACING LEADS Daig Corp. DTB Class III 1986-12-05
K862697 AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY) Advanced Vascular Technologies, Inc. DSY Class II 1986-12-05
K863643 EPICARDIA, PC/FD Medicomp, Inc. DSI Class II 1986-12-05
K864428 MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. DTB Class III 1986-12-05
K864585 ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH Advanced Cardiovascular Systems, Inc. DQX Class II 1986-12-05
K864564 MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-12-05
K862463 LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC Nihon Kohden America, Inc. DRT Class II 1986-12-05
K860814 DSP100 AMPLIFIER Intl. Acoustics, Inc. DQC Class I 1986-12-05
K863046 ULTRA SOFTWARE MODULE: MODEL 2016 Cardiac Pacemakers, Inc. KRG Class III 1986-12-05
K850449 DIGITAL PULSE METER HRM-100E & ETC. Sanyo Electric, Inc. DRT Class II 1986-12-04
K863210 VELCOM-100 Waters Instruments, Inc. DPW Class II 1986-11-26
K864506 SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1 Spacelabs, Inc. DSI Class II 1986-11-25
K863231 D100 COMPUTER CARDIAC ANALYSIS SYSTEM Dextra Medical, Inc. DXG Class II 1986-11-25
K863476 SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO Scimed Life Systems, Inc. DTZ Class II 1986-11-25
K863230 D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM Dextra Medical, Inc. DXG Class II 1986-11-25
K864461 MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY Medsurg Industries, Inc. DWS Class I 1986-11-24
K863558 URESIL CAROTID SHUNT Uresil Corp. DWF Class II 1986-11-24
K864505 SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 Spacelabs, Inc. DSI Class II 1986-11-24
K863921 DAIG TYPE O4 VS-1 CONNECTOR Daig Corp. DTB Class III 1986-11-24
K863784 NELLCOR N-200 (PULSE OXIMETER) Nellcor, Inc. DQA Class II 1986-11-21
K863534 LIFE-WATCH MONITOR LT-8 Computerized Medical Systems, Inc. DRT Class II 1986-11-21
K863366 PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE Labeltape Meditect, Inc. DRX Class II 1986-11-21
K863427 CLAMPEASE FA Freund Medical Products DXC Class II 1986-11-20
K864155 MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS American Edwards Laboratories DTJ Class I 1986-11-20
K862316 CASE 12 Marquette Electronics, Inc. DSI Class II 1986-11-20
K863030 630C ELECTROCARDIOGRAPH Quinton, Inc. DPS Class II 1986-11-20
K863596 CHIN-FOGARTY INFLATION DEVICE American Edwards Laboratories DXT Class II 1986-11-20
K864287 MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-11-20
K863138 TERUMO RADIFOCUS GUIDE WIRE Terumo Medical Corp. DQX Class II 1986-11-20
K863724 MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM Oxford Medilog, Inc. DSI Class II 1986-11-20
K864002 MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-11-20
K863845 EM III DISPOSABLE ELECTRODE Electromed Intl., Ltd. DRX Class II 1986-11-20
K862200 FORTEC MI-100, BLOOD PRESSURE METER Fortec Electronic Corp./Nam Tai DSK Class II 1986-11-18
K863515 MODIFIED SARNS OXYGENATOR SYSTEM 3M Health Care, Sarns DTZ Class II 1986-11-18
K863541 STOCKERT-SHILEY CAPS HLM INTERFACE Shiley, Inc. DTQ Class II 1986-11-18
K863593 SARNS SAFETY LOOP 3M Health Care, Sarns DWD Class II 1986-11-18
K863672 MODEL (MB-700) BLOOD PRESSURE MONITOR Sharp Electronics Corp. DXN Class II 1986-11-18
K862714 BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM) Electro-Diagnostic Instruments DSB Class II 1986-11-17
K861023 DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER Diagnostic Electronics Corp. DPW Class II 1986-11-17
K854279 NORELCO ELECTRONIC DIGITAL BP METER HC3030 Philips Park DXN Class II 1986-11-17
K855048 NORELCO DIGITAL BLOOD PRESSURE METER HC3001 Philips Park DXN Class II 1986-11-17
K862720 VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES Sonicaid, Inc. DPW Class II 1986-11-17
K863899 K-STIK DEFIBRILLATION PADS Katecho, Inc. LDD Class II 1986-11-12
K852547 CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON Cortronic Corp. DQO Class II 1986-11-10
K862841 HIGH VELOCITY CW DOPPLER SYSTEM Biosound, Inc. DPW Class II 1986-11-10
K863186 BIOCHEM CO/OX 1000 Biochem International, Inc. DQA Class II 1986-11-07
K862553 ECG MODULE Elscint, Inc. DPS Class II 1986-11-07
K860994 DECITEL AUSCULSCOPE Bloomfield Research and Development, Inc. DQD Class II 1986-11-07
K855177 NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER Philips Park DXN Class II 1986-11-07
K860734 SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR Marquette Electronics, Inc. DPS Class II 1986-11-06
K863372 SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES Interspec, Inc. DPT Class II 1986-11-04
K862913 CARDIOSCAN WITH DOPPLER OPTION Interspec, Inc. JOP Class II 1986-11-04
K864047 MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. DTB Class III 1986-11-03
K864048 MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. DTB Class III 1986-11-03
K863781 MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD Intermedics, Inc. DTB Class III 1986-11-03
K864141 CORDIS CONTRAST INJECTION LINES Cordis Corp. DQO Class II 1986-11-03
K862190 WALRUS: DOUBLE BALLOON SHUNTING CATHETER Medical Parameters, Inc. DWF Class II 1986-11-03
K863581 MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB The Kendal Co. JOW Class II 1986-10-31
K863537 CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY Cordis Corp. DXT Class II 1986-10-31
K862740 QUINTON Q.CATH Quinton, Inc. DQK Class II 1986-10-31
K862966 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) Oscor Medical Corp. DTB Class III 1986-10-31
K863404 CARDIOLIFE TEC 7100 Nihon Kohden America, Inc. LDD Class II 1986-10-31
K863405 CARDIOLIFE TEC 7200 Nihon Kohden America, Inc. LDD Class II 1986-10-31
K862451 LUER LOCK SKIRT Hewlett-Packard Co. DTL Class II 1986-10-31
K863547 MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE Medtronic Vascular DRO Class II 1986-10-31
K862634 TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT Research Medical, Inc. DWF Class II 1986-10-31
K863402 MEDI-PLAST DISPOSABLE MANIFOLD Medi-Plast Intl., Inc. DTL Class II 1986-10-22
K863249 OXYGENATOR MODEL NO. BENTLEY-10 PLUS American Bentley DTZ Class II 1986-10-20
K863922 VERSAFLEX(TM) DELTA ST(TM) MONITOR Versaflex Delivery Systems, Inc. DSH Class II 1986-10-20
K860646 PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART Analogic Corp. DPS Class II 1986-10-16
K863177 CORDIS ANGIOPLASTY HEMOSTASIS DEVICES Cordis Corp. DTL Class II 1986-10-15
K863863 CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE) Cardionostics, Inc. DSH Class II 1986-10-15
K863564 URESIL IRRIGATION CATHETER Uresil Corp. DQY Class II 1986-10-10
K863559 URESIL OCCLUSION BALLOON CATHETER Uresil Corp. DQT Class II 1986-10-10
K863139 TERUMO RADIFOCUS INTRODUCER KIT Terumo Medical Corp. DYB Class II 1986-10-10
K863137 TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER Terumo Medical Corp. DQO Class II 1986-10-10
K863417 CORDIS MULTICOR II MODEL 402D PACER Cordis Corp. DXY Class III 1986-10-08
K863582 MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) Cook Pacemaker Corp. DXY Class III 1986-10-08
K863365 MODIFICATION OF STERILITY CYCLE PARAMETERS Coratomic, Inc. DXY Class III 1986-10-08
K863331 SIREDOC 60 AND SIREDOC 220 Siemens Medical Solutions USA, Inc. DSF Class I 1986-10-06
K863159 Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR Quinton, Inc. DSI Class II 1986-10-06
K862973 STOCKERT-SHILEY CAPS TIMER MODULE Shiley, Inc. DTQ Class II 1986-10-01
K862117 TRACKER INFUSION CATHETER Target Therapeutics DQY Class II 1986-10-01
K860638 NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. DSP Class II 1986-10-01
K863661 MEDCOMP DISPOSABLE MANIFOLD SYSTEM Medical Components, Inc. DTL Class II 1986-09-29
K863337 CORDIPAK CARDIAC CATHETERIZATION PACK Angi-Pak Corp. DQO Class II 1986-09-29
K861641 HEPARIN-COATED EXTRACORPOREAL CIRCUITS American Bentley DTZ Class II 1986-09-29
K863045 PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 Cardiac Pacemakers, Inc. KRG Class III 1986-09-29
K862920 BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR C.R. Bard, Inc. DTN Class II 1986-09-29
K862617 SENSORMEDICS OXYSHUTTLE(TM) Sensor Medics Corp. DQA Class II 1986-09-26
K862596 DR-2C (MODIFICATION) General Devices DSF Class I 1986-09-26
K862937 BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE Versaflex Delivery Systems, Inc. DQX Class II 1986-09-24
K862455 MODIFIED CARDIOCAP MONITOR Datex Division Instrumentarium Corp. DSK Class II 1986-09-24
K863418 MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE Intermedics, Inc. DXY Class III 1986-09-24
K862918 SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM Scimed Life Systems, Inc. DTZ Class II 1986-09-23
K863480 BIOTRONIK PERMANENT PACEMAKER ELECTRODE Biotronik Sales, Inc. DTB Class III 1986-09-23
K863037 USCI (R) DISPOSABLE INFLATION DEVICE C.R. Bard, Inc. DXT Class II 1986-09-23
K862975 MODIFIED PTCA GUIDING CATHETERS Cordis Corp. DQY Class II 1986-09-23

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