meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
1982-10-18

Clearances · page 174 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K822820 GAS-FLOW METER GFL 10 Gambro, Inc. DTX Class II 1982-10-18
K822821 GAMBRO BLOOD LEVEL DETECTOR LCS 10 Gambro, Inc. DTW Class II 1982-10-18
K822822 GAMBRO PRESSURE MONITOR PRM 10 Gambro, Inc. DXS Class II 1982-10-18
K822876 MODEL 78534A PATIENT MONITOR Hewlett-Packard Co. DRT Class II 1982-10-18
K822874 THERMOSTATIC WATER MIXING VALVE TWV10 Gambro, Inc. DWC Class II 1982-10-18
K822862 BRACHIAL CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQO Class II 1982-10-18
K821989 NON-STETHO 7, UM-15TP Hirata Sangyo Co. USA, Inc. DXN Class II 1982-10-18
K822616 LS6 ARRYTHMIA DISCRIMINATOR Life Science Instrumentation, Inc. DSI Class II 1982-10-18
K822877 MODEL 78554A DATA MGMT. PLUG-IN MODULE Hewlett-Packard Co. DXG Class II 1982-10-18
K822586 TEFLON COATED GUIDE WIRES & CATHETER Universal Medical Instrument Corp. DQX Class II 1982-10-18
K822878 MODEL 78553A PRESSURE PLUG-IN MODULE Hewlett-Packard Co. DSK Class II 1982-10-18
K820882 PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC Datascope Corp. DSP Class II 1982-10-18
K822695 SIGNAL DISTRIBUTION NETWORK #78581A Hewlett-Packard Co. DRT Class II 1982-10-15
K822692 DIGITAL PULSE METER (73 BWS) #HRM-100E Sanyo Electric, Inc. DRT Class II 1982-10-15
K822904 MODEL 325D UNIPOLAR CARDIAC PULSE GEN Cook Pacemaker Corp. DXY Class III 1982-10-15
K822723 SWAN-GANZ BIPOLAR PACING CATHETER American Edwards Laboratories DYG Class II 1982-10-15
K822798 DISPOSABLE ELECTRODE #1900 Andover Medical, Inc. DRX Class II 1982-10-15
K822003 BALLOON TEMP. PACING CATHETER Ziehm International, Inc. LDF Class II 1982-10-15
K822002 BIPOLAR TEMP. PACING CATHETER W/STYLETET Ziehm International, Inc. LDF Class II 1982-10-15
K822239 COAXIAL BIPOLAR PACING ELECTRODE Burditt & Calkins-Siemens-Elema DTB Class III 1982-10-04
K822652 JAIN INSULATING BOOT MODEL 225B Cook Pacemaker Corp. DXY Class III 1982-10-04
K822297 ENERTRAX MODEL 7100E Medtronic Vascular DXY Class III 1982-10-04
K822687 REUSABLE FOGARTY FLEXIBLE CALIBRATOR American Edwards Laboratories DWP Class II 1982-10-04
K822768 ELECTROCARDIOGRAPH (74 DPS) #YM-102 Sanyo Electric, Inc. DPS Class II 1982-10-04
K822425 M-MODE ANALYSIS SYSTEM User Resources, Inc. DXK Class II 1982-10-04
K821711 CARDIO TEHCHANALYZER Cardio Technology , Ltd. DSI Class II 1982-10-04
K822363 ALTA III ECG RECORDER Scole Engineering Co. DSH Class II 1982-10-04
K822718 SERIES 7000 BEDSIDE PATIENT MONITOR Marquette Electronics, Inc. DSI Class II 1982-10-04
K822309 COMMAND NP Cardiac Pacemakers, Inc. DXY Class III 1982-10-04
K822590 PRESSURE ISOLATION AMPLIFIER #9813 517 Honeywell, Inc. DRJ Class I 1982-10-04
K822522 CUTANEOUS PRESSURE PLETHYSMOGRAPH Life Sciences Manufacturing, Inc. DSB Class II 1982-09-28
K822536 MARK V Medrad, Inc. DXT Class II 1982-09-28
K822593 PERCUTANEOUS CATHETER INTRODUCER SET Vertex Medical Corp. DYB Class II 1982-09-28
K822595 VESSEL DILATOR Vertex Medical Corp. DRE Class II 1982-09-28
K822598 TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS Vertex Medical Corp. DQO Class II 1982-09-28
K822640 CORONARY INFUSION KIT Mallinckrodt Critical Care DQO Class II 1982-09-28
K822030 MULTIPLE LEAD ARRHYTHMIA MODULE Marquette Electronics, Inc. DSI Class II 1982-09-28
K822594 POLYETHYLENE CARDIOVASCULAR CATHETER Vertex Medical Corp. DQO Class II 1982-09-28
K822455 VASOGRAPH, MODEL MV-2 Electro-Diagnostic Instruments DSB Class II 1982-09-24
K822390 LIFE TRACE 24 Life Science Instrumentation, Inc. DRT Class II 1982-09-21
K822093 STAT-SCAN Survival Technology, Inc. DXG Class II 1982-09-21
K822615 LIFE WATCH LSI Life Science Instrumentation, Inc. DRT Class II 1982-09-21
K822438 BIOMEGA MODEL 59W Bio Mega Diagnostic, Inc. DXN Class II 1982-09-21
K822389 LIFE TRACE 40/42 Life Science Instrumentation, Inc. DRT Class II 1982-09-21
K822582 QUIKPAGE SCANNER Agilent Technologies DPS Class II 1982-09-21
K822596 VERTEX PERCUTANEOUS PUNCTURE NEEDLE Vertex Medical Corp. DQO Class II 1982-09-21
K822597 GUIDE WIRE Vertex Medical Corp. DQX Class II 1982-09-21
K822614 BLOOD PRESSURE MONITORING DEVICES Allied Healthcare Products, Inc. DXN Class II 1982-09-21
K822316 HEART MONITOR BRACELET ALARM Hmba DRI Class I 1982-09-21
K822517 SINGLE CHANNEL NONFADE OSCILLOSCOPE Quinton, Inc. DXJ Class II 1982-09-14
K822319 RE1000 HEART RATE MONITOR Electronic Monitors, Inc. DRT Class II 1982-09-14
K822507 DISPOSABLE TRANSDUCER & ACCESSORIES Gould, Inc. DRS Class II 1982-09-14
K821716 BARD PTFE VASCULAR PROSTHESIS C.R. Bard, Inc. DSY Class II 1982-08-31
K822245 INDEFLATOR Advanced Cardiovascular Systems, Inc. LIT Class II 1982-08-31
K821190 GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1982-08-31
K822290 STERILE PROTECTIVE SLEEVE W/TOUGH-BORST Universal Medical Instrument Corp. DQO Class II 1982-08-31
K822317 ARGYLE CAROTID ARTERY LOOP SHUNT Sherwood Medical Co. DWF Class II 1982-08-31
K822294 VPD-261 DEFIBRILLATOR MONITOR Life Science Instrumentation, Inc. LDD Class II 1982-08-31
K822236 FRANKLIN QUANTIC 1200 Bruce Franklin, Inc. DXK Class II 1982-08-31
K821758 QUINTON Q, SCAN MODELS 900 & 901 Quinton, Inc. DPS Class II 1982-08-25
K821816 ANGIOGRAPHIC CATHETER Medi-Tech, Inc. DQO Class II 1982-08-24
K822210 SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES 3M Health Care, Sarns DWF Class II 1982-08-24
K822068 GAMBRO PUMP CONSOLE CSL Gambro, Inc. DTQ Class II 1982-08-24
K822033 BERMAN ANGIOGRAPHIC BALLOON CATHETER Ziehm International, Inc. DQO Class II 1982-08-24
K822071 PUMP MODULES PMO LO-110-PMD 10-210 Gambro, Inc. DWB Class II 1982-08-24
K822388 LIFE TRACE 14 Life Science Instrumentation, Inc. DRT Class II 1982-08-24
K822350 SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH American Edwards Laboratories DYG Class II 1982-08-24
K822243 GUIDING CATHETER Interventional Medical, Inc. DQO Class II 1982-08-24
K821942 HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 Harvey-Bostwick, Inc. DRT Class II 1982-08-24
K822155 ETHICON TEMPORARY CARDIAC PACING WIRE ETHICON, Inc. LDF Class II 1982-08-24
K822100 HIGH PRESSURE CONTRAST INJECTION LINE Namic DQO Class II 1982-08-24
K822034 BALLOON WEDGE PRESSURE CATHETER Ziehm International, Inc. DYG Class II 1982-08-24
K821532 PERIGUARD PERICARDIAL PATCH Genetic Laboratories, Inc. DXZ Class II 1982-08-19
K822247 CATH-SEAL Universal Medical Instrument Corp. DYB Class II 1982-08-19
K821065 DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL Datascope Corp. DSP Class II 1982-08-19
K821538 CAPIOX CR-CARDIOTOMY RESERVOIR Terumo Medical Corp. DTP Class II 1982-08-06
K821947 FASTPASS IMPLANTABLE ENDOCARD. PACING Pacesetter Systems DTB Class III 1982-08-06
K821316 KONTRON LITWAK-KOFFSKY OBTURATED CANNU Kontron Instruments, Inc. DWF Class II 1982-08-06
K822147 MEDTRONIC ENERTRAX MODEL 7100 Medtronic Vascular DXY Class III 1982-08-06
K822246 NONINVASIVE TEMPORARY PACEMAKER Ross Research, Inc. DRO Class II 1982-08-06
K821889 POROUS SURFACED PLATINUM IRIDIUM Cordis Corp. DTB Class III 1982-08-06
K820989 MEDTRONIC #6993 Medtronic Vascular DTB Class III 1982-08-06
K820609 HEART *AID, #80 Cardiac Resucitator Corp. DRO Class II 1982-08-06
K821673 HEART*AID, ALS, MODEL 95 Cardiac Resucitator Corp. DRO Class II 1982-08-06
K820507 PACE* AID MODEL 50 Cardiac Resucitator Corp. DRO Class II 1982-08-06
K822020 CKG 8000 Cardio Kinetics, Inc. DSB Class II 1982-08-06
K821152 HEART AID #90 Cardiac Resucitator Corp. DRO Class II 1982-08-06
K821445 ARGYLE FERGUSON LEFT ATRIAL VENT CATH Sherwood Medical Co. DWF Class II 1982-07-30
K821802 CENTURION ELECTRODE BELT Clinical Data, Inc. DRX Class II 1982-07-30
K821846 LDS MONITORING ELECTRODE Life Design Systems, Inc. DRX Class II 1982-07-30
K821434 EKG (ECG) ELECTRODES Dupaco, Inc. DRX Class II 1982-07-30
K822097 D645-BACTERIOLOGICAL GAS LINE FILTER Electromedics, Inc. KRI Class I 1982-07-30
K821996 LEONARD PERIPHERAL VENOUS PRESSURE CATH Norton Performance Plastics Corp. DYG Class II 1982-07-30
K821888 AUTOMATIC SINGLE CHANNEL ECG #399 Birtcher Corp. DPS Class II 1982-07-30
K821959 CARDIO-RESPIRATORY MONITOR MODEL CR-1 Electromed Intl., Ltd. DRT Class II 1982-07-20
K821894 DISPOSABLE TRANSDUCER DOMES & KITS American Pharmaseal Div. Ahsc DRS Class II 1982-07-20
K821976 ANGIOGRAPHY KIT Mallinckrodt Critical Care DQO Class II 1982-07-20
K821612 MODEL 16800 TREND RECORDER Healthdyne, Inc. DSF Class I 1982-07-14
K821696 THE SOFT PEDAL Habco Products, Inc. JOW Class II 1982-07-14
K821614 AS20 MONITORING SYSTEM Narco Scientific DXN Class II 1982-07-14

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