meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
1981-07-10

Clearances · page 179 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K811253 CASSETTE READER American Edwards Laboratories DSH Class II 1981-07-10
K811254 PAPER CHART RECORDER American Edwards Laboratories DSF Class I 1981-07-10
K811781 TENSIOMETER Vivitek, Inc. DXN Class II 1981-07-10
K811638 DATASCOPE INTERNAL DEFIBRILLATOR PADDLES Datascope Corp. LDD Class II 1981-07-10
K811453 NOVATRACER RECORDER Novametrix Medical Systems, Inc. DSF Class I 1981-07-10
K811216 RESIDENT BEDSIDE MONITOR Abbott Laboratories DRT Class II 1981-07-02
K810928 ENDOCARDIAL ELECTRODE Vitatron Medical BV DTB Class III 1981-07-02
K811626 MEDDARS/ULTRA IMAGER PULSE/PHON MODULE Honeywell, Inc. DQC Class I 1981-07-01
K811539 CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL Cordis Corp. DTB Class III 1981-07-01
K803086 MYOWIRE-ATEMPORARY CARDIAC PACING WIRE Craig & Craig, Inc. LDF Class II 1981-07-01
K811350 UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. Medtronic Vascular DXY Class III 1981-07-01
K811092 STERILE PACKAGING Telectronics, Inc. DTE Class II 1981-07-01
K811635 NORELCO DIGITAL BLOOD PRESSURE METER North American Philips Corp. DXN Class II 1981-06-30
K811349 MODEL 5866-24 LEAD ADAPTOR KIT Medtronic Vascular DTD Class II 1981-06-30
K811276 OCCLUSION CATHETER Bionomy, Inc. DYG Class II 1981-06-30
K811121 CENTRAL STATION MONITORING SYSTEMS Cambridge Instruments, Inc. DPS Class II 1981-06-30
K811636 NORELCO ELECTRONIC BLOOD PRESSURE METER North American Philips Corp. DXN Class II 1981-06-30
K811512 TELETRACE TELEPHONE EKG SYSTEM Medtronic Vascular DXH Class II 1981-06-30
K811148 VITA-STAT MODEL 9000-S Viat-Stat DSK Class II 1981-06-30
K811146 VITA-STAT MODEL 8000-C Vita-Stat DSK Class II 1981-06-30
K811634 NORELCO ANEROID BLOOD PRESSURE METER North American Philips Corp. DXQ Class II 1981-06-30
K811147 VITA-STAT MODEL 9000-A Vita-Stat DSK Class II 1981-06-30
K811560 AUTOMATED PHYSIOLOGIC PROFILE MONITOR Life Sciences Manufacturing, Inc. DXG Class II 1981-06-18
K811537 MODEL SP 5507 5-LUMEN THERMODILUTION CAT Gould, Inc. KRB Class II 1981-06-18
K810885 #326 PROGRAMMABLE CARD. PULSE GENERATOR Cook Pacemaker Corp. DXY Class III 1981-06-16
K811527 CC-103 Anthro-Metrics Corp. DSI Class II 1981-06-16
K810884 #325 PROGRAMMABLE CARD. PULSE GENERATOR Cook Pacemaker Corp. DXY Class III 1981-06-16
K811122 DEL MAR AVIONICS MODELS 9400 & 9401 Del Mar Avionics DSI Class II 1981-06-12
K811411 SWAN-GANZ HEPARIN COATED, ETC. CATHETER American Edwards Laboratories KRB Class II 1981-06-12
K811414 BAIM CORONARY SINUS FLOW ANALYZER Electro-Catheter Corp. DXG Class II 1981-06-12
K811538 MODELS TA 1017 & 1017T GRITIFLO DISPOS Gould, Inc. DRS Class II 1981-06-12
K811410 MEDI-TRACE Graphic Controls Corp. KRA Class II 1981-06-12
K811079 SYPHGMOLOG Cardiodyne General, Inc. DSK Class II 1981-06-12
K811379 SHILEY ARTERIAL FILTER Shiley, Inc. DTM Class II 1981-06-09
K811480 THERMODILUTION KIT American Pharmaseal Div. Ahsc KRB Class II 1981-06-09
K811399 EDSLAB CLOSED INJECTATE DELIVERY SYSTEM American Edwards Laboratories KRB Class II 1981-06-09
K811368 CARDIOPLEGIA COOLING & ADMIN. SETS Bentley Laboratories, Inc. KRI Class I 1981-06-09
K811348 CARDIOPULMONARY BYPASS ACCESSORY EQUIP. Bentley Laboratories, Inc. KRI Class I 1981-05-29
K810142 ELA MEDICAL UNILITH PULSE GENERATOR Ela Medical, Inc. DXY Class III 1981-05-29
K810489 MULTILITH PULSE GENERATOR #1140 Ela Medical, Inc. DXY Class III 1981-05-29
K811062 CAMPBRIDGE COMPUTRACE Cambridge Instruments, Inc. DXG Class II 1981-05-29
K803208 SIRECUST 358 Siemens Corp. DSI Class II 1981-05-27
K811221 INTERMEDICS CYBERLITH BIPOLAR CARDIAC Intermedics, Inc. DXY Class III 1981-05-27
K811123 MEDTRONIC PULSE GENERATOR Medtronic Vascular DXY Class III 1981-05-27
K811106 INTERMEDICS POLY FLEX ENDOCARDIAL PACING Intermedics, Inc. DTB Class III 1981-05-27
K810677 MODELS 5976/5977 PACEMAKER PULSE GENER Medtronic, Inc. DXY Class III 1981-05-27
K811204 BRONCHEK-SHILEY CARDIAC JACKET & BSC J Shiley, Inc. DTR Class II 1981-05-21
K811208 MODEL 1100 SPHYGMOMANOMETER Y DSK Class II 1981-05-21
K810398 APC IMPLANTABLE PACING LEAD, MODEL 3266 American Pacemaker Corp. DTB Class III 1981-05-15
K811188 NORELCO BLOOD PRESSURE METER North American Philips Corp. DXN Class II 1981-05-15
K810397 APC IMPLANTABLE PACING LEAD-FLANGE #3260 American Pacemaker Corp. DTB Class III 1981-05-15
K810808 CORATOMIC MODEL OVALITH-920 Coratomic, Inc. DXY Class III 1981-05-15
K810894 FOGARTY FLEXIBLE CALIBRATOR American Edwards Laboratories DWP Class II 1981-05-15
K810399 APC IMPLANTABEL PACING LEAD, MODEL 3264 American Pacemaker Corp. DTB Class III 1981-05-15
K810734 MODELS 8420 THRU 8423 PACEMAKER GENER Medtronic Vascular DXY Class III 1981-05-15
K810396 APC IMPLANTABLE PACING LEAD, TINED #3262 American Pacemaker Corp. DTB Class III 1981-05-15
K811236 DISPOSABLE HOLDER FOR HANCOCK AORTIC Vascor, Inc. DTJ Class I 1981-05-13
K811235 DISPOSABLE HOLDER FOR HANCOCK MITRAL Vascor, Inc. DTJ Class I 1981-05-13
K810895 ESOPHAGEAL PILL ELECTRODE Con Med Equipment, Inc. DRX Class II 1981-05-13
K810735 DISPOSABLE, STERILE TRANSDUCER DOMES Bio-Med Corp. DRS Class II 1981-05-08
K811004 MANIFOLD American Pharmaseal Div. Ahsc DTZ Class II 1981-05-08
K810845 DOUBLE VELOUR GRAFTS Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1981-05-08
K810635 ELECTRODE BLOOD PRESSURE MONITOR Sears, Roebuck & Co. DSK Class II 1981-05-08
K810297 DATASCOPE PERCOR=DL DUAL-LUMEN INTRA Datascope Corp. DSP Class II 1981-05-06
K810988 IBM 5885 DIGITAL ECG ACQUISITION CART Intl. Business Machines DPS Class II 1981-05-01
K810752 THINLITH III UNIPOLAR CARDIAC PULSE GEN. Intermedics, Inc. DXY Class III 1981-05-01
K810800 MODEL 230-05 CYBERLITH I BIPOL. PULSE G. Intermedics, Inc. DXY Class III 1981-05-01
K810872 EEG TELEPHONE RECEIVER MODEL #AFR-J Telediagnostic Systems, Inc. DXH Class II 1981-05-01
K811066 MODEL 230-06 CYBERLITH TM I BIPOLAR IN Intermedics, Inc. DXY Class III 1981-05-01
K810608 TRANSMITTER & RECEIVERS, TELEPHONE, ELEC Heart Check Systems, Inc. DXH Class II 1981-05-01
K811016 CC-100 Anthro-Metrics Corp. DPS Class II 1981-05-01
K810962 ARROW VESSEL CATHETER. KIT W/20GA INDWEL Arrow Intl., Inc. DQY Class II 1981-04-29
K810637 COBE DISPOSABLE PRESSURE TRANSDUCER Cobe Laboratories, Inc. DRS Class II 1981-04-23
K810529 DIRECT WRITING VECTORCARDIOGRAPH Elmed, Inc. DYC Class II 1981-04-23
K810515 DISPOSABLE 2-STAGE CANNULA Texas Medical Products, Inc. DWF Class II 1981-04-23
K810851 SPECTRUM ANALYZER 8000 Radionics Medical, Inc. DXG Class II 1981-04-23
K810505 CARDIOPULMONARY BYPASS OXYGENATOR Cobe Laboratories, Inc. DTZ Class II 1981-04-23
K810532 DISPOSABLE STOPCOCK Texas Medical Products, Inc. DTZ Class II 1981-04-23
K810551 PACEMAKER LEAD ADAPTER Pacesetter Systems DTD Class II 1981-04-23
K810924 MEDRAD HIGH PRESSURE CONECTING TUBE Medrad, Inc. DWE Class II 1981-04-17
K810508 SONTEK ANGIOGRAPHIC CATHETER Sontek Corp. DQO Class II 1981-04-17
K810470 SHILEY S-100A (ADULT) BLOOD OXYGENATOR Shiley, Inc. DTZ Class II 1981-04-17
K810849 CORDIS BIOPSY FORCEPS Cordis Corp. DWZ Class II 1981-04-17
K810604 ELECTRODE/PACER SYSTEM ANALYZER PMA 400 Telectronics, Inc. DTC Class II 1981-04-14
K810901 INSULATIVE COATING FOR CARD. PULSE GEN Intermedics, Inc. DXY Class III 1981-04-14
K810603 IMPLANTABLE PROGRAMMABLE CARDIAC PULSE Telectronics, Inc. DXY Class III 1981-04-14
K810859 SINGLE USE SELDINGER/COURNAND PERC. NDL Procedure Products, Inc. DRE Class II 1981-04-11
K810698 PHARMALOG Circadian, Inc. DSH Class II 1981-04-10
K810828 NON-INVASIVE AMPLIFIER Henry Ford Hospital DRR Class II 1981-04-10
K810561 DOPSCAN MODEL 1050 Carolina Medical Electronics DPW Class II 1981-04-10
K810643 UNIVERSAL PACING ELECTRODE KIT Stanco Medical, Inc. LDF Class II 1981-04-08
K810642 ATRIAL-VENTRICULAR PACING ELECTRODE KIT Stanco Medical, Inc. LDF Class II 1981-04-08
K810657 TEMPTRON #'S 6804/6805 Medtronic Vascular LDF Class II 1981-04-08
K810647 SHILEY OXYGENATOR THERMISTOR PROBE Shiley, Inc. DWC Class II 1981-04-03
K810820 CARDIOPULMONARY BYPASS Dlp, Inc. DWF Class II 1981-04-03
K810755 SQUINN VITATEK 500 SERIES PHYSIOL. MONI Vitatek DRT Class II 1981-04-03
K810838 NEONATAL BLOOD PRESSURE CUFF Invivo Research Labs, Inc. DXQ Class II 1981-04-03
K810566 SIEMENS MODEL 146-146A EXTERNAL PULSE G Cynergy DTE Class II 1981-04-01
K810383 INTERMEDICS CYBERLITH I BIOPOLAR CARDI Intermedics, Inc. DXY Class III 1981-04-01
K810385 CYBERLITH I PULSE GENERATOR MODEL 253-04 Intermedics, Inc. DXY Class III 1981-04-01

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