meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1987-08-24

Clearances · page 152 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K872133 OXYGENATOR MODEL NO. BENTLEY 5 PLUS American Bentley DTZ Class II 1987-08-24
K872220 ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION) Advanced Cardiovascular Systems, Inc. DQX Class II 1987-08-21
K865098 SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 Telectronics, Inc. DTB Class III 1987-08-18
K871212 MASCOT CW DOPPLER SYSTEM Imex Medical Systems, Inc. JOP Class II 1987-08-14
K870545 ANDRIES PHYSICAL ASSESSMENT COMPUTER Andries Tek, Inc. DQC Class I 1987-08-14
K872485 CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) Ideas For Medicine, Inc. DXE Class II 1987-08-12
K870215 DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) Cook, Inc. LIT Class II 1987-08-12
K871422 OLYMPUS ANGIOSCOPY PUMP Olympus Corp. DQI Class II 1987-08-12
K871587 THE TELESCAN C.A.R.E. SYSTEM Telescan Medical Systems DSH Class II 1987-08-12
K871992 IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. DXY Class III 1987-08-12
K872161 DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET Shiley, Inc. DTL Class II 1987-08-12
K871080 PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER Catheter Technology Corp. DQY Class II 1987-08-12
K872248 DOUBLE LUMEN CATHETER Cordis Corp. DQO Class II 1987-08-12
K872159 DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES Shiley, Inc. DWF Class II 1987-08-12
K872234 TRANSCOR RADIO-STETHOSCOPE MB Transcor, Inc. DSH Class II 1987-08-11
K870442 QUANTASCOPE Vital Science Corp. DXR Class II 1987-08-11
K870607 SSD-725 ULTRASOUND SECTOR SCANNER Ge Medical Systems Information Technologies JOP Class II 1987-08-10
K871866 MEDTRONIC CLASSIX MODELS 8436/8437/8438 Medtronic Vascular DXY Class III 1987-08-10
K870150 CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM Cardio Metrics, Inc. JOP Class II 1987-08-07
K871441 ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE Nitto Denko America, Inc. DRX Class II 1987-08-03
K872154 MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH Ideas For Medicine, Inc. DQT Class II 1987-08-03
K871844 ARGYLE VASCULAR BYPASS SET Sherwood Medical Co. DWF Class II 1987-08-03
K871774 CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS Gish Biomedical, Inc. DTR Class II 1987-08-03
K872551 SEAMED MODEL 3200 Seamed Corp. DTE Class II 1987-07-31
K872144 MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER Vestra-Subco, Inc. DXQ Class II 1987-07-29
K871418 VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) Critikon Company, LLC DXN Class II 1987-07-29
K872229 VITEL III, ECG TRANSMITTER Equimed Corp. DSH Class II 1987-07-29
K871886 MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT Draeger Medical, Inc. DXN Class II 1987-07-29
K871720 MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER A&D Engineering, Inc. DSK Class II 1987-07-29
K871400 SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING Ge Medical Systems Information Technologies DXK Class II 1987-07-24
K872246 MODIFIED MODEL 9431 TELETRACE TRANSMITTER Medtronic Vascular DSH Class II 1987-07-21
K872443 COMPANION 50 REGULATOR/FLOWMETER Puritan Bennett Corp. DRT Class II 1987-07-21
K872249 SIRECUST MODEL 960 AND 961 PATIENT MONITORING Medical Electronics Laboratories, Inc. DRT Class II 1987-07-21
K872354 SERIES 2000 BEDSIDE PATIENT MONITOR Marquette Electronics, Inc. DRT Class II 1987-07-21
K861374 SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282 Kontron Instruments, Inc. DXN Class II 1987-07-21
K870916 SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS. Ge Medical Systems Information Technologies JOP Class II 1987-07-21
K871137 MINISTIK MINI PUNCTURE SET CATALOG CODE #57505 Dlp, Inc. DQX Class II 1987-07-16
K872157 HALL VEIN STRIPPER Solco Basle, Inc. DWQ Class II 1987-07-07
K865010 MICOR Siemens Medical Solutions USA, Inc. DQK Class II 1987-07-06
K870810 DORCHES(TM) LIFESOUND(TM) Centauri Manufacturing, Inc. DQD Class II 1987-06-29
K871826 PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE Datex Division Instrumentarium Corp. DQA Class II 1987-06-29
K870578 NIGHTWATCH(TM) SYSTEM Buckman Co., Inc. DSH Class II 1987-06-29
K872012 LECTEC NON-INVASIVE PACING ELECTRODE Lectec Corp. DRO Class II 1987-06-29
K863791 SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX Gish Biomedical, Inc. DQY Class II 1987-06-25
K871272 HUNTLEIGH FLOWPAC FP2000 Huntleigh Technology, Inc. DRM Class II 1987-06-25
K864411 PULSE/B.P. MONITOR Pulse Time Products, Ltd. DXN Class II 1987-06-24
K871986 MODEL 5600B PROGRAMMER, PACEMAKER Telectronics, Inc. KRG Class III 1987-06-24
K863589 MODEL 600 VASCULAR DUPLEX IMAGER Multigon Industries, Inc. DXK Class II 1987-06-24
K871775 STAT-VAC CHEST DRAINAGE SYSTEM Gish Biomedical, Inc. DTN Class II 1987-06-24
K863790 J-CATH, GISH MODEL NO. JVAC-XXXX Gish Biomedical, Inc. DQY Class II 1987-06-24
K871971 MODIFIED PACE*AID MODEL 53 Cardiac Resucitator Corp. DRO Class II 1987-06-24
K871944 FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) Futurecare Systems, Inc. DSH Class II 1987-06-24
K871538 STAT-PAD (TM) Cardiac Resucitator Corp. DRO Class II 1987-06-24
K871153 CATHETER INTRODUCER Angeion Corp. DYB Class II 1987-06-24
K871864 PB240 PATIENT MONITOR/PULSE OXIMETER Puritan Bennett Corp. DQA Class II 1987-06-24
K871718 MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER A&D Engineering, Inc. DSK Class II 1987-06-24
K871794 EASY READ(TM) Health O Meter DXN Class II 1987-06-19
K864994 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER Aries Medical, Inc. DSP Class II 1987-06-19
K864537 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER Aries Medical, Inc. DSP Class II 1987-06-19
K871436 PREDICTOR Corazonix Corp. DQK Class II 1987-06-19
K872087 UMSC HOLTER MONITORING KIT United Medical Supply Co., Inc. DSH Class II 1987-06-19
K871686 GEM-CRIT CHECK Diamond Sensor Systems DRY Class II 1987-06-18
K871021 GUIDING CATHETERS 9F JL4 Devices For Vascular Intervention, Inc. DQO Class II 1987-06-16
K864614 LP-3 ELECTROCARDIOGRAPH Fidelity Medical, Inc. DPS Class II 1987-06-16
K870375 MODEL 617 CARDIAC OUTPUT COMPUTER Omnimed B.V. DXG Class II 1987-06-16
K871596 IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) Shiley, Inc. DTJ Class I 1987-06-15
K870356 TATCH-IT Reunion Medical Co. DRS Class II 1987-06-12
K871371 DIGITAL SPHYGMOMANOMETER Omron Tateisi Electronics Co. DRS Class II 1987-06-12
K863702 PULSE CUFF RECORDER MODEL PCR100 Imex Medical Systems, Inc. JOM Class II 1987-06-12
K871890 CARDIO-MEGA SYSTEM Grandcor Medical Systems DSI Class II 1987-06-12
K871668 BIODAN TYPE COMET ELECTRODE National Medical Technology DRX Class II 1987-06-10
K871748 THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE The Buddy Systems, Inc. DRX Class II 1987-06-10
K864278 DS-II DIGITAL SONOGRAPHY SYSTEM Intl. Acoustics, Inc. DQD Class II 1987-06-10
K871915 MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 Pace Medical DTE Class II 1987-06-10
K870819 BUBBLE TRAP CAT. NO. B-180 American Omni Medical, Inc. DWF Class II 1987-06-08
K871350 PREBYPASS FILTER American Omni Medical, Inc. KRJ Class II 1987-06-08
K871569 MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR Cardiac Resucitator Corp. DRO Class II 1987-06-08
K871353 OXIMETER Radiometer America, Inc. DQA Class II 1987-06-08
K871325 BOWEN REUSEABLE/DISPOSABLE ELECTRODE Bowen & Company, Inc. DRX Class II 1987-06-08
K871149 DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER Iontec Corp. DRT Class II 1987-06-05
K871221 CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 Cardiovascular Devices, Inc. DRY Class II 1987-06-05
K871363 MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE Quinton, Inc. DXN Class II 1987-06-05
K871482 HYPERTENSION RISK DETECTOR(TM) Pearce Clinical Laboratories, Inc. DXN Class II 1987-06-05
K871719 MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER A&D Engineering, Inc. DXN Class II 1987-06-05
K871040 CONSULTANT BODY COMPOSITION ANALYZER Body Composition Analog, Inc. DSB Class II 1987-06-05
K870460 DORROS(TM) SMALL VESSEL PTA CATHETER C.R. Bard, Inc. DXN Class II 1987-06-05
K871208 UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M Pacesetter Systems DYB Class II 1987-06-05
K871861 IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. DXY Class III 1987-06-05
K871626 ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200 Jason Marketing Co. DRX Class II 1987-06-05
K871239 ACUSON PHYSIOLOGICAL CONTROL MODULE Acuson Computed Sonography DPS Class II 1987-06-05
K870411 CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA. Medical Surgical Concepts, Inc. DQY Class II 1987-06-02
K864745 POET OXIMETER Criticare Systems, Inc. DQE Class II 1987-06-02
K870413 PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) Medical Surgical Concepts, Inc. DRE Class II 1987-06-01
K871207 OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C Omron Electronics, Inc. DXN Class II 1987-05-28
K871659 IMS-2000S STRESS MONITOR Integrated Medical Systems, Inc. DXG Class II 1987-05-28
K870016 ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) Migada, Ltd. DTB Class III 1987-05-28
K870412 TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT Medical Surgical Concepts, Inc. DQY Class II 1987-05-27
K863969 CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D Camino Laboratories, Inc. DXO Class II 1987-05-27
K870421 TDMAC-HEPARIN COATED RMI Research Medical, Inc. DWF Class II 1987-05-22
K871425 ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1987-05-22

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