meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1981-10-13

Clearances · page 178 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K812530 TRANSDUCER DOME Biomeal Corp. DRS Class II 1981-10-13
K811593 ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J Telectronics, Inc. DTB Class III 1981-10-13
K812674 INFANT CARIDAC MONITOR Electromed Intl., Ltd. DRT Class II 1981-10-13
K812539 PRE-BYPASS FILTER Gelman Sciences, Inc. KRJ Class II 1981-10-13
K812502 IMPLANTAID LEAD INTRODUCER #319-10 & 12 Intermedics, Inc. DYB Class II 1981-10-13
K812676 AMPLITONE-3 Progressive Technology, Inc. LDE Class I 1981-10-13
K812218 KALOS-03 Biotronik Sales, Inc. DXY Class III 1981-10-13
K812517 CARDIAC PACING ELECTRODES Medics Instrument Corp. LDF Class II 1981-10-13
K812221 INTERMEDICS POLY FLEX EPICARDIAL SUTURE Intermedics, Inc. DTB Class III 1981-10-06
K812245 INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL Intermedics, Inc. DTB Class III 1981-10-06
K812609 VASCULAB #VSC21 Medasonics, Inc. JOM Class II 1981-10-02
K812639 UNICUFF Frontier Products DXP Class II 1981-10-02
K812608 VASCULAB #R12B Medasonics, Inc. DSF Class I 1981-10-02
K812515 CARDIAC REVIEW STATION Diasonics, Inc. DXG Class II 1981-10-02
K812640 URE SIL EMBOLECTOMY/THROMBECTOMY CATH Uresil Corp. DXE Class II 1981-10-02
K812147 CARDIORATER CR-7 Life Science Instrumentation, Inc. DRT Class II 1981-09-25
K812145 CARDIORATER CR-3 Life Science Instrumentation, Inc. DRT Class II 1981-09-25
K812324 FLOW-DIRECTED THERMODILUTION CATHETER Sorensen Research DYG Class II 1981-09-25
K812146 CARDIORATER CR-5 Life Science Instrumentation, Inc. DRT Class II 1981-09-25
K812563 SWAN-GANZ & EDSLAB HEPARIN COATED CATH. American Edwards Laboratories DYG Class II 1981-09-25
K812144 CENTERAL MONITOR 360 Life Science Instrumentation, Inc. DRT Class II 1981-09-25
K812276 DISPOSABLE ELECTRODE, #1610 Andover Medical, Inc. DRX Class II 1981-09-25
K812519 2000 SERIES PORTABLE RESUSCITATION SYST. Life Science Instrumentation, Inc. LDD Class II 1981-09-25
K812520 280/4 MINI-DEFIBRILLATOR Life Science Instrumentation, Inc. LDD Class II 1981-09-25
K812354 KONTRON PMS 7000 Kontron Instruments, Inc. DQK Class II 1981-09-25
K801337 CYBERLITH IX IMPLANTABLE PULSE GENERATOR Intermedics, Inc. DXY Class III 1981-09-23
K801339 TELEMETRY DECODER Intermedics, Inc. DXY Class III 1981-09-23
K811464 MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY Intermedics, Inc. DXH Class II 1981-09-23
K812580 MEDTRONIC MODEL 2409 Medtronic Vascular DXY Class III 1981-09-23
K812325 INTK-08 8 FRENCH INTRODUCER KIT W/SIDE Sorensen Research DYB Class II 1981-09-21
K812307 USCI TRANSTHORACIC TEMP. PACING ELECTROD C.R. Bard, Inc. LDF Class II 1981-09-21
K812317 DEFIBRILLATOR/MONITOR Hewlett-Packard Co. LDD Class II 1981-09-21
K812131 PORTAPULSE Gavon, Inc. DRT Class II 1981-09-21
K812259 NIVP MONITOR Datascope Corp. DXN Class II 1981-09-21
K811425 CARDIACMONITORS Pulse Time Products, Ltd. DRT Class II 1981-09-16
K812096 MEDTRONIC ENERTRAX MODEL 7100 Medtronic Vascular DXY Class III 1981-09-16
K812270 PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL Diag Corp. DTB Class III 1981-09-16
K811841 GORE-TEX CARDIOVASCULAR PATCH W. L. Gore & Associates, Inc. DXZ Class II 1981-09-16
K811441 MANUFACTURING PROCESS CHANGE Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1981-09-16
K812184 ANGIOSCAN SPECTRUM ANALYZER Unigon Industries, Inc. DXK Class II 1981-09-09
K811893 NOVAMETRIX PHYSIOLOGICAL MONITOR #910 Novametrix Medical Systems, Inc. DRT Class II 1981-09-08
K812254 DACRON PLEDGET SUTURE BUTTRESS ETHICON, Inc. DXZ Class II 1981-08-31
K811999 BO MED BIA Bomed Medical Mfr., Ltd. DSB Class II 1981-08-31
K812149 CARDIO-DATA SYSTEM, #MARK III Cardio Data DSI Class II 1981-08-31
K810890 NEOLOOPS Medical Marketing Systems DWS Class I 1981-08-31
K812271 CENTRAL STATION MONITOR Datascope Corp. DRT Class II 1981-08-31
K812153 MEDTRONIC SPECTRAX Medtronic Vascular DXY Class III 1981-08-31
K812168 CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH. Cordis Corp. LIT Class II 1981-08-31
K812243 INTERFACE CARDIOTOMY BLOOD FILTER #51 Medical, Inc. JOD Class II 1981-08-25
K812148 ELECTRONIC STETHOSCOPE #S-50 Syphgmostat DQD Class II 1981-08-25
K812244 INTERFACE PRE BYPASS PRIME FILTER #90 Medical, Inc. KRJ Class II 1981-08-25
K812240 INTERFACE PRE BYPASS PRIME FILTER Medical, Inc. KRJ Class II 1981-08-25
K811510 GORE-TEX VASULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1981-08-20
K812173 FLUSHFLO II Bentley Laboratories, Inc. KRA Class II 1981-08-18
K812143 INTRODUCER, PERCUTANEOUS Willson DYB Class II 1981-08-18
K811971 CORDIS DUCOR PTR SYSTEM Cordis Corp. DQY Class II 1981-08-13
K811615 BACH-SIMPSON MODEL BVM30 Bach-Simpson , Ltd. DPW Class II 1981-08-13
K811920 ADAPTAID LEAD ADAPTER, #365-17 Intermedics, Inc. DTD Class II 1981-08-13
K811540 SPACELABS' SYSTEM AUTORECORDER Spacelabs, Inc. DSF Class I 1981-08-13
K811950 KENL-ECG Suzuken Co., Ltd. DPS Class II 1981-08-13
K812059 SPHGOMOMANOMETER Med-Tek Corp. DXN Class II 1981-08-13
K811742 HEMOTHERM MODEL 400 Cincinnati Sub-Zero DWJ Class II 1981-08-13
K811376 ULTRASONIC QFM SYSTEM 1000 Narco Bio-Systems DPW Class II 1981-08-13
K811616 BACH-SIMPSON MODEL TS266 Bach-Simpson , Ltd. DPW Class II 1981-08-13
K811200 PACEPATH IMPLANTABLE ENDOCARD. PACING LD Pacesetter Systems DTB Class III 1981-08-13
K812093 COBE HEAT EXCHANGER RESERVOIR MODULE Cobe Laboratories, Inc. DTR Class II 1981-08-13
K811581 ARRHYTHMIA FUNCTION BLOCK Honeywell, Inc. DSI Class II 1981-08-13
K811949 KENL-ECG-3 Suzuken Co., Ltd. DPS Class II 1981-08-13
K811595 SP-100-B SMALL PARTS SCANNER SYSTEM Highstoy DXK Class II 1981-08-12
K810414 USCI DOPPLER CATHETER SYSTEM C.R. Bard, Inc. JOP Class II 1981-08-12
K811872 TEFLON PLEDGET SUTURE BUTTRESS ETHICON, Inc. DXZ Class II 1981-08-12
K811246 DOPPLER ULTRASOUND BLOOD FLOWMETER Irex Corp. DPW Class II 1981-08-12
K811938 ADAPTAID LEAD ADAPTER #365-25 Intermedics, Inc. DTD Class II 1981-08-07
K810494 TYPE FH ENDOCARDIAL LEAD Biotronik Sales, Inc. DTB Class III 1981-08-07
K811879 MODEL A UNIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. DTB Class III 1981-08-03
K811876 MODEL D BIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. DTB Class III 1981-08-03
K811878 MODEL B BIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. DTB Class III 1981-08-03
K811372 MODEL 84 TRANSPORT SYSTEM Datascope Corp. DSP Class II 1981-08-03
K811877 MODEL C UNIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. DTB Class III 1981-08-03
K811758 ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR Powers Medical Systmes DXH Class II 1981-08-03
K812009 CARDIOTOMY RESERVOIR W/FILTER#BCR-3500 Bentley Laboratories, Inc. DTN Class II 1981-07-28
K811911 SINGLE CHANNEL NON-FADE OSCILLOSCOPE Quinton, Inc. DXJ Class II 1981-07-28
K811980 ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN H.R. Biomedical, Ltd. DRS Class II 1981-07-28
K812008 CORDIOTOMY RESERVOIR Bentley Laboratories, Inc. DTN Class II 1981-07-28
K811987 OXY-QUIK MARK IV OXYGEN INHALATOR Oxequip Health Ind. DRM Class II 1981-07-27
K811402 COMMAND P5(BIPOLAR PULSE GENERATOR) Cardiac Pacemakers, Inc. DXY Class III 1981-07-27
K811318 TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880 Medtronic Vascular LDF Class II 1981-07-20
K811391 OXIMETRIX ACCU SAT CPB Oximetrix, Inc. DRY Class II 1981-07-20
K811964 VISITEC NEEDLE RANGE (CARDIOVASCULAR) Visitec Co. DRC Class II 1981-07-20
K811691 CORDIS OMNI-ARTICOR CARDIAC PACER #308 Cordis Corp. DXY Class III 1981-07-20
K811910 VEIN-TRAP TM Atrium Medical Corp. DWQ Class II 1981-07-20
K811217 PACEMAKER PROGRAMMER #2010 Cardiac Pacemakers, Inc. KRG Class III 1981-07-20
K810887 ELA MEDICAL UNILITH 7540 PULSE GENERATOR Ela Medical, Inc. DXY Class III 1981-07-20
K811768 CORATOMIC MODEL OVALITH-920BP Corptomic DXY Class III 1981-07-20
K811341 BIOVISION CARDIAC STROBE Cardiac Imaging DPS Class II 1981-07-16
K810940 THE BETA Burdick Corp. DSI Class II 1981-07-16
K811743 MAXITHERM Cincinnati Sub-Zero DWJ Class II 1981-07-16
K811909 CARDIOPULMUNARY RESUSCITATOR Michigan Instruments, Inc. DRM Class II 1981-07-16
K811792 ARRYTHMIA PRINTER OPTION American Edwards Laboratories DSI Class II 1981-07-10
K811556 DC-1 CARDIAC IMAGING MODULE Diasonics, Inc. DXK Class II 1981-07-10

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