meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1984-10-26

Clearances · page 166 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842150 TRANSDUCER-MONITOR INTERFACING Millar Instruments, Inc. DXO Class II 1984-10-26
K841336 NON-INVASIVE BP MODULE 7000 Marquette Electronics, Inc. DXN Class II 1984-10-26
K842473 IMPLANTABLE PROGRAMMABLE PULSE GENERAT Telectronics, Inc. DXY Class III 1984-10-26
K841103 NONINVASIVE BLOOD PRESSURE MEASURE SYS Panasonic Co. Div. Matsu Elec. Corp. America DXN Class II 1984-10-26
K832076 ELECTRONIC BLOOD PRESS. METER EN-212 Panasonic Co. Div. Matsu Elec. Corp. America DXN Class II 1984-10-26
K842213 VSM R1 Physio-Control Corp. DXO Class II 1984-10-26
K840646 CARDIOTRODE Kholber Corp. DRX Class II 1984-10-26
K843503 AEGIS AMBULATORY MONITORING SYSTEM Aegis Medical Systems, Inc. DSI Class II 1984-10-26
K840020 FITNESS LOGGER Britt Corp., Inc. DPS Class II 1984-10-26
K840032 TELEPHONE RECEIVERS R101 R111 Biometric Products, Inc. DXH Class II 1984-10-26
K843709 COBE SATURATION CELL Cobe Laboratories, Inc. DRY Class II 1984-10-24
K841868 MINGOGRAF 7 Siemens Medical Solutions USA, Inc. DSH Class II 1984-10-24
K841613 PRESSURE TRANSDUCER DOME 1295C Hewlett-Packard Co. DRS Class II 1984-10-24
K843383 MEDI-TECH DILATATION CATHETERS Medi-Tech, Inc. LIT Class II 1984-10-24
K842200 MD308H DIGITAL/MB351H AUTO-BP MONITOR Sharp Electronics Corp. DXN Class II 1984-10-24
K841961 MILLS OPERATIVE PERIPHERAL ANGIOPLASTY Scimed Life Systems, Inc. LIT Class II 1984-10-23
K843448 SCIMED PM200 INFLATION MANOMETER Scimed Life Systems, Inc. MAV Class II 1984-10-23
K843642 SUBCLAVIAN LEAD INTRODUCER SYS Xanmed Corp. DYB Class II 1984-10-23
K843641 CATHETER INTRODUCER SYSTEM Xanmed Corp. DYB Class II 1984-10-23
K843513 EPICARDIA, PC Medicomp, Inc. DSI Class II 1984-10-22
K843836 THERMAL GRAYSCALE RF-100 Fukuda Denshi USA, Inc. DSF Class I 1984-10-19
K843396 LS-260G MONITOR/RECORDER & DEFIBILLATOR Life Science Instrumentation, Inc. LDD Class II 1984-10-19
K841959 CARDIO METRIC CUSTOM PERFUSION TUBING Sterile Design, Inc. DWE Class II 1984-10-19
K842460 VF-PD-120 Valpey-Fisher Corp. JOP Class II 1984-10-19
K841263 CARDIOSCAN - TM BEING APPLIED FOR Interspec, Inc. DXK Class II 1984-10-19
K841802 ELECTRODE CATHETER, ORTHOGONAL TYPE Webster Laboratories, Inc. LDF Class II 1984-10-18
K843287 ARRHYTHMIA CENTRAL OCC-7101 Nihon Kohden America, Inc. DSI Class II 1984-10-18
K841416 PEDIATRIC DIAG. CRITERIA OPTION 5600C Hewlett-Packard Co. DSI Class II 1984-10-18
K843719 SINGLE WALL INTRODUCER NEEDLE Ocean Medical Products, Ltd. DYB Class II 1984-10-18
K842624 LIFEPAK 8 Physio-Control Corp. LDD Class II 1984-10-18
K843229 LIFEPAK 200 Physio-Control Corp. LDD Class II 1984-10-18
K842616 SPACELABS ALPHA PC PATIENT COMPUTER Spacelabs, Inc. DSI Class II 1984-10-18
K843409 FLOW-DIRECTED THERMODILUTION CATH Andover Medical, Inc. DYG Class II 1984-10-18
K843500 FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN Cardio-Vascular Innovations, Inc. DYB Class II 1984-10-18
K843542 SHILEY CORONARY CARDIOPLEGIA ADAPTOR Shiley, Inc. DWF Class II 1984-10-18
K843726 NAMIC ADB ANGIOGRAPHIC DUMP BAG North American Instrument Corp. DQO Class II 1984-10-18
K843411 THERMAL DILUTION CATHETER Andover Medical, Inc. DYG Class II 1984-10-18
K843444 ARGYLE SILICONE LEFT VENTRICULAR AND Sherwood Medical Co. DWF Class II 1984-10-18
K843538 PO 2 LYTRODE Polystan C/O Vitalcor, Inc. DRY Class II 1984-10-18
K842829 HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS North American Instrument Corp. DTL Class II 1984-10-18
K843837 MEDTRONIC 5984-5984LP-5985 Medtronic Vascular DXY Class III 1984-10-17
K842394 ASTRA 2, ASTRA 3, 4 & 6 Cardiac Pacemakers, Inc. DXY Class III 1984-10-17
K831822 TETRAFLEX INTEGRALLY SUPPORTED PTFE Shiley, Inc. DSY Class II 1984-10-16
K841958 CARDIO METRICS CARDIOTOMY RESERVOIR Sterile Design, Inc. JOD Class II 1984-10-15
K832753 PERCUTANEOUS BALLOON Smec, Inc. DSP Class II 1984-10-13
K843501 BALLOON DILATION CATHETER Advanced Cardiovascular Systems, Inc. LIT Class II 1984-10-04
K842640 SPACELABS ICR ARRHYTHMIA MASTER I HOLTER Spacelabs, Inc. DSI Class II 1984-10-04
K841256 MODELS 78551A 78552A Hewlett-Packard Co. DXG Class II 1984-10-02
K841363 HEART RATE/RESPIRATION SIMULATOR 8310 Aequitron Medical, Inc. DRT Class II 1984-10-02
K842144 GORE-TEX VASCULAR GRAFT, FEP-RINGED W. L. Gore & Associates, Inc. DYF Class II 1984-10-01
K843718 PROGRAMMABLE STIMULATOR 5326 Medtronic Vascular JOQ Class II 1984-09-27
K842364 HANDHELD PACEMAKER PROGRAMMER & SOFTWAR Cardiac Pacemakers, Inc. KRG Class III 1984-09-24
K840668 ELECTRODE PACEMAKER, PERM & TEMP Vitatron Medical BV DTB Class III 1984-09-24
K843393 LIFELINE TLE 476-04 Intermedics, Inc. DTB Class III 1984-09-24
K843394 LIFELINE TLE 484-02 Intermedics, Inc. DTB Class III 1984-09-24
K840209 SERVOMED MEDIVISION SCOPE SMV-235 Litton Medical Electronics DXJ Class II 1984-09-20
K843060 SENTRA Cardiac Pacemakers, Inc. DTD Class II 1984-09-20
K843263 ARROW-JOHANS ECG ADAPTOR Arrow Intl., Inc. DQY Class II 1984-09-20
K840832 SERVOMED OXCARDIORE SPIROGRAPH 324/111 Litton Medical Electronics DRT Class II 1984-09-20
K842462 HOLTER SCREENING MONITOR HS-221 Advantage Medical Systems, Inc. DRT Class II 1984-09-11
K833594 FUKUDA DENSHI FX-302 AUTO/THREE CHAN Brentwood Instruments, Inc. DRT Class II 1984-09-11
K843261 ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD Angiosystems, Inc. DRE Class II 1984-09-11
K833171 MONITORING KIT Transamerica Delaval, Inc. DRS Class II 1984-09-06
K843141 CRITIKON HEPARIN-COATED CARDIOVASCULAR Critikon Company, LLC LDF Class II 1984-09-04
K842954 CARDIONOSTICS HOLTER DURA-LITE RECORDE Cardionostics, Inc. DSH Class II 1984-09-04
K831697 TELECTRONICS MODEL 2401 Seamed Corp. DTC Class II 1984-09-04
K843089 MEDTRONIC 8437/8438 Medtronic Vascular DXY Class III 1984-08-29
K841499 LIFESCOPE II Nihon Kohden America, Inc. DRT Class II 1984-08-28
K841501 LIFESCOPE 6 OEC-6102 Nihon Kohden America, Inc. DRT Class II 1984-08-28
K841502 LIFESCOPE 6 OEC-6105 Nihon Kohden America, Inc. DRT Class II 1984-08-28
K841500 LIFESCOPE 6 OEC-6201 Nihon Kohden America, Inc. DSI Class II 1984-08-28
K842194 PRESSURE MONITOR Norton Texas Medical Products DXS Class II 1984-08-27
K840391 ANGIOGRAPHIC PROCEDURE TRAY Triad Medical Division DQX Class II 1984-08-27
K842667 EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE Marquette Electronics, Inc. LDD Class II 1984-08-27
K842235 SERVOCARD DEFIBRILLATOR SCP-851 Litton Datamedix LDD Class II 1984-08-27
K842645 CARDIAC SUPPLY TRAY Deroyal Industries, Inc. DQY Class II 1984-08-27
K831809 FOGARTY OCCLUDER PAD Thomas J. Fogarty, M.D. DXC Class II 1984-08-27
K842889 ARGYLE CUSTOM TUBING PACK Sherwood Medical Co. DWF Class II 1984-08-27
K842620 CARDIOTOMY RESERVOIR W/FILTER BCR-3500 American Bentley DTN Class II 1984-08-27
K842831 BAIM CORONARY SINUS FLOW CALCULATOR Electro-Catheter Corp. DXG Class II 1984-08-27
K842312 SERVOCARD SCP-840 Litton Datamedix LDD Class II 1984-08-27
K843009 BP-1000 Pollenex Associated Mills, Inc. DXN Class II 1984-08-24
K842486 ELECTRONIC DIGITAL BP METER HC 3001 North American Philips Corp. DXN Class II 1984-08-24
K841095 BP800, 850 1000 Associated Mills, Inc. DXN Class II 1984-08-24
K833737 CPR LOCATOR Lifepoint,Inc LIX Class II 1984-08-24
K834408 TX-2 THERMAL DILUTION CARDIAC OUTPUT Waters Instruments, Inc. DXG Class II 1984-08-23
K843262 TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO Hewlett-Packard Co. JOP Class II 1984-08-23
K840055 DYNASCOPE SERIES Fukuda Denshi USA, Inc. DRT Class II 1984-08-22
K840009 NOVA 12 CARDIAC OUTPUT COMPUTER Nova Medical Specialties DXG Class II 1984-08-22
K841275 FINE NEEDLE ASPIRATION DEVICE Gyneco, Inc. DRM Class II 1984-08-17
K842337 SHILEY VENOUS RESERVOIR Shiley, Inc. DTN Class II 1984-08-17
K841639 NOVA BALLOON THERMODILUTION CATH. Nova Medical Specialties DYG Class II 1984-08-12
K833170 FLUSH DEVICE Transamerica Delaval, Inc. DRS Class II 1984-08-12
K841640 NOVA BALLOON THERMODILUTION INFUSION Nova Medical Specialties DYG Class II 1984-08-12
K841797 MULTIPRO CATHETER Shiley, Inc. DQY Class II 1984-08-10
K842503 GAMBRO PULSATILE MONITOR PLM 10-200 Gambro, Inc. DWA Class II 1984-08-10
K842556 ADVANCED CARDIOVASCULAR BALLOON DILATA Advanced Cardiovascular Systems, Inc. LIT Class II 1984-08-10
K842711 SHILEY CARDIOTOMY RESERVOIR W/FILTER Shiley, Inc. DTN Class II 1984-08-10
K834429 PERIPHERAL DILATATION ANGIOPLASTY-CATH American Edwards Laboratories LIT Class II 1984-08-10
K842375 VENOUS CANNULA W/BENT, TIP WIRE Dlp, Inc. DWF Class II 1984-08-10

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