meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
1983-11-03

Clearances · page 170 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K833095 TRANSDUCER DOME SD105 Sorensen Research DRS Class II 1983-11-03
K832772 SATURN-24HR. HOLTER SCANNER Hittman Medical Systems DSI Class II 1983-11-03
K832827 CORPULS 300 Automated Medical Products, Inc. LDD Class II 1983-11-03
K833094 TRANSDUCER DOME SD104 Sorensen Research DRS Class II 1983-11-03
K831696 PORTABLE DEFIBRILLATOR MONITOR 74DRK Honeywell, Inc. LDD Class II 1983-11-03
K832324 THERMAL DILUTION CATHETER Catheter Corp. of America DYG Class II 1983-11-03
K831397 FRENCH INTRA-AORTIC 9.5 BALLOON ON KON Datascope Corp. DSP Class II 1983-11-02
K831307 PECOR 8.5 FRENCH IAB ON A DATASCOPE Datascope Corp. DSP Class II 1983-11-02
K832014 MULTISCRIPTOR EK #403 VARIOUS MODEL Litton Medical Electronics DPS Class II 1983-10-31
K832015 MULTISCRIPTOR EK VARIOUS #43 Litton Medical Electronics DPS Class II 1983-10-31
K832130 MULTISCRIPTOR EK 36/101 047 02,05 Litton Medical Electronics DPS Class II 1983-10-31
K831818 CENTRAL STATION MONITOR CSM-100 Honeywell, Inc. DRT Class II 1983-10-31
K832013 LME PATIENT MONITOR SMS 151 Litton Medical Electronics DPS Class II 1983-10-31
K831817 PATIENT MONITOR #RM-100 Honeywell, Inc. DRT Class II 1983-10-31
K832017 LME BLOOD PRESSURE MONITOR Litton Medical Electronics DSK Class II 1983-10-31
K832184 SIMPLISCRIPTOR EK 31/101 037 16 Litton Medical Electronics DPS Class II 1983-10-31
K832018 SERVOMED COMPACT MONITOR 181/10105002 Litton Medical Electronics DRT Class II 1983-10-31
K832012 MEDICAL ELECTRONICS-PRINTER CLOCK Litton Medical Electronics DSF Class I 1983-10-31
K832924 VENOUS RESERVOIR Shiley, Inc. DTN Class II 1983-10-31
K833199 SILICONE RUBBER ISOLATION SLEEVE 350-01 Intermedics, Inc. DXY Class III 1983-10-28
K831967 CRITIKON CARDIAC OUTPUT COMPUTER Critikon Company, LLC DXG Class II 1983-10-28
K831860 GENERATOR, PULSE, PACEMAKER #532 Vitatron Medical BV DXY Class III 1983-10-27
K831859 PACEMAKER PROGRAMMER #2032 Vitatron Medical BV DXY Class III 1983-10-27
K833198 SILICONE RUBBER ISOLATION SLEEVE 351-01 Intermedics, Inc. DXY Class III 1983-10-27
K831274 WLECTROCARDIOGRAPH ECG-7204 Nihon Kohden America, Inc. DSI Class II 1983-10-27
K832016 LME HEART-RATE MONITOR Litton Medical Electronics DRT Class II 1983-10-26
K832026 SERVOMED BASIC BEDSIDE UNIT SMS 108 W/ Litton Medical Electronics DRT Class II 1983-10-26
K832041 SERVOMED STANDARD SMS 104 Litton Medical Electronics DRT Class II 1983-10-26
K832024 SERVOMED BASIC BEDSIDE UNIT - VARIOUS Litton Medical Electronics DRT Class II 1983-10-26
K831894 BLOOD OXYGENATOR 5070 Shiley, Inc. DTZ Class II 1983-10-20
K833099 BIOTRONIK N, BIPOLAR PEB-60/4-N Biotronik Sales, Inc. DTB Class III 1983-10-20
K831804 MULTIPOLAR TEMPORARY CARDIAC Oscor, Inc. LDF Class II 1983-10-20
K832784 ULTRA LIGHT RAAF CATHETER Quinton, Inc. DQY Class II 1983-10-20
K831854 USCI ANGIOGRAPHIC BALLOON CATHETER C.R. Bard, Inc. DYG Class II 1983-10-20
K833106 BIOTRONIK DFH UNIPOLAR PE-60/4-DFH Biotronik Sales, Inc. DTB Class III 1983-10-20
K831458 CARDIOPLEGIA RECIRCULATION SYS-BL 705/A Electromedics, Inc. DWB Class II 1983-10-20
K831695 TEMP. CARDIAC PACING WIRE TME 60/61/65 Oscor, Inc. LDF Class II 1983-10-20
K832417 HYPOTHERMIC MYCARDIAL PROTECTION DEV 3M Health Care, Sarns DTR Class II 1983-10-20
K832579 PHYSIOLOGICAL PRESS. MEASUREMENT CATH Camino Laboratories, Inc. DXO Class II 1983-10-20
K831751 LEAD INTRODUCER SETS-EB-S8 & EB-S12 Oscor, Inc. DYB Class II 1983-10-20
K831997 IMPLANTABLE ENDOCARDIAL PACING LEADS Oscor, Inc. DTB Class III 1983-10-20
K832395 HOLTA-MED RECORDER Holta-Med DSH Class II 1983-10-20
K832987 PERMANTHANE #866 BIPOLAR COAXIAL Pacesetter Systems DTB Class III 1983-10-20
K832604 PHYSIOLOGICAL PRESSURE MEASUREMENT CATH Camino Laboratories, Inc. DXO Class II 1983-10-20
K832528 MGI STRENGTH/FITNESS SYS-MODEL #PU-101 Mgi Strength/Fitness Systems, Inc. JOM Class II 1983-10-20
K833048 PURGES LINES, PL-45 & PL-33 American Bentley DTM Class II 1983-10-20
K832060 ACCU-SPHYG Olympic Medical Corp. DXN Class II 1983-10-19
K831057 VIDEO-DILUTION TECH. MARK I INSTRUMENT Angio Tec Corp. DXG Class II 1983-10-19
K833101 BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC Biotronik Sales, Inc. DTB Class III 1983-10-19
K831865 IONESCU-SHILEY LOW POROSITY COMPOSITE Shiley, Inc. DSY Class II 1983-10-19
K833108 BIOTRONIK I-UNIPOLAR PE-60/2-13 Biotronik Sales, Inc. DTB Class III 1983-10-19
K832287 NOVA BALLOON THERMODILUTION INFUSION Nova Medical Specialties DYG Class II 1983-10-19
K831880 IONESCU-SHILEY LOW POROSITY AORTIC GRAFT Shiley, Inc. DSY Class II 1983-10-19
K832625 TOP THREE WAY STOPCOCK Top Surgical Manufacturers Co. DTL Class II 1983-10-19
K831245 TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO Ritter Co. DXN Class II 1983-10-19
K833098 BIOTRONIK DN UNIPOLAR PE-60/4-DN & Biotronik Sales, Inc. DTB Class III 1983-10-19
K832850 ELECATH PACEWEDGE DUAL PRESS. BIPOLAR Electro-Catheter Corp. LDF Class II 1983-10-19
K833104 BIOTRONIK D2K UNIPOLAR PE-60/4 Biotronik Sales, Inc. DTB Class III 1983-10-19
K832386 PERCLUDER DL OCCLUDING BALLOON Datascope Corp. DQO Class II 1983-10-19
K831944 PATIENT MONITOR #78832A Hewlett-Packard Co. DRT Class II 1983-10-19
K831895 BLOOD OXYGENATOR 50 70/S Shiley, Inc. DTZ Class II 1983-10-19
K832475 AXIOM PERFUSSION CANNULA Axiom Medical, Inc. DWF Class II 1983-10-19
K831943 PATIENT MONITOR 788 33A Hewlett-Packard Co. DRT Class II 1983-10-19
K832561 EPCOR MULTIELECTRODE TEMP. PERVENOUS Cordis Corp. LDF Class II 1983-10-19
K832212 PATIENT SELECTOR FUNCTION BLOCK Honeywell, Inc. DPS Class II 1983-10-14
K831428 AS 1740 INTERFACE MODULE Narco Scientific DRT Class II 1983-10-14
K831407 CARDIAC OUTPUT COMPUTER Ziehm International, Inc. DXG Class II 1983-10-14
K831429 AS 191 ECG TELEMETRY MODULE Narco Scientific DPS Class II 1983-10-14
K831633 QUANTUM BIPOLAR CARDIAC PULSE GENERATOR Intermedics, Inc. DXY Class III 1983-10-12
K832893 MODEL 329T PROGRAMMABLE, BIPOLAR CARDI Cook Pacemaker Corp. DXY Class III 1983-10-04
K831481 DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN Eugene Scarberry DSK Class II 1983-10-04
K832171 SELF CHECK DIGITAL BLOOD PRESS. MONITOR Ritter Co. DXN Class II 1983-10-04
K832474 FOGARTY-CHIN PERIPHERAL DILATION CATH American Edwards Laboratories LIT Class II 1983-09-29
K831787 PATIENT MONITOR #78353A Hewlett-Packard Co. DRT Class II 1983-09-29
K831878 CARDIO-SCOPE MINI MONITOR W.E. Leder Enterprises, Inc. DPS Class II 1983-09-29
K832554 FOGARTY 6MM SOFTJAW CLIP American Edwards Laboratories DXC Class II 1983-09-29
K832704 SHILEY GAS FILTER Shiley, Inc. KRI Class I 1983-09-29
K832806 CORONARY ANASTOMOSIS MARKING SYSTEM Biotrac Laboratories DSY Class II 1983-09-29
K831752 BIOCHECK PEC-108 PROGRAM-PULSE MONITOR Biotechnology, Inc. DRT Class II 1983-09-29
K832957 FLOW-DIRECTED HEPARIN COATED THERMODIL Sorensen Research DYG Class II 1983-09-29
K832044 SHILEY MULTIPRO CATHETER Shiley, Inc. DXE Class II 1983-09-29
K832811 SHILEY 3L CARDF PLUS Shiley, Inc. DTP Class II 1983-09-20
K832594 PRE-BYPASS FILTER #EC-PBF SERIES Gish Biomedical, Inc. KRJ Class II 1983-09-20
K832411 GASLINE FILTER #GF-10 American Bentley KRI Class I 1983-09-12
K832058 ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV. Parke-Davis Co. KRA Class II 1983-09-12
K831422 BIOFLOW Bomed Medical Mfr., Ltd. DSB Class II 1983-09-12
K831421 BOMED BIOCON Bomed Medical Mfr., Ltd. DSB Class II 1983-09-12
K831430 AIR SHIELDS AS-100 MONIORING SYS-AS105 Narco Scientific DRT Class II 1983-09-12
K831977 C TEC SERIES 9000 E.C.G. ELECTRODE Speywood Medical, Ltd. DRX Class II 1983-09-09
K831381 RAPID ATRIAL PACER Seamed Corp. DTE Class II 1983-08-31
K832595 VESSEL DILATOR Abbott Laboratories DWP Class II 1983-08-31
K830863 HANCOCK PERICARDIAL PATCH Extracorporeal Medical Specialities, Inc. DXZ Class II 1983-08-31
K832023 EMBOLECTOMY CATHETER Bionomy, Inc. DXE Class II 1983-08-31
K831636 PERCUTANEOUS INTRODUCER KIT Accu-Line DQY Class II 1983-08-24
K831771 IMPLANTABLE PROGRAM. CARDIAC PULSE GEN Telectronics, Inc. DXY Class III 1983-08-16
K830806 VASCULAR GRAFT/BIFURCATED/FEP-RINGED W. L. Gore & Associates, Inc. DXZ Class II 1983-08-13
K831578 PHYSIOLOGICAL MONITOR #902 Novametrix Medical Systems, Inc. DRT Class II 1983-08-12
K832255 MODEL F UNIPOLAR ENDOCARDIAL LEAD- Cook Pacemaker Corp. DTB Class III 1983-08-12
K831659 FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE American Edwards Laboratories LIT Class II 1983-08-12
K831506 DISP. TRANSDUCER W/MONITORING KIT TRANS Sorensen Research DRS Class II 1983-08-12

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