meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1985-07-26

Clearances · page 162 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K852883 MEDILOG M3 Oxford Medilog, Inc. DSI Class II 1985-07-26
K852884 MEDILOG M1 Oxford Medilog, Inc. DSI Class II 1985-07-26
K853034 #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ Intermedics, Inc. DXY Class III 1985-07-25
K850898 MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER Medi-Trace Products Division DRS Class II 1985-07-25
K853017 ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 Ela Medical, Inc. DXY Class III 1985-07-25
K844484 HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA Vitatron Medical BV KRG Class III 1985-07-24
K851335 COACH TM- THE AEROBIC FITNESS MONITOR Biotechnology, Inc. DRT Class II 1985-07-24
K851664 MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO Sharp Electronics Corp. DXN Class II 1985-07-24
K841092 HIGH PRESSURE FLEX. CONNECTING TUBING Tronomed, Inc. DXT Class II 1985-07-24
K851496 ECG MONITOR MODEL RM102 Honeywell, Inc. DXJ Class II 1985-07-24
K851848 PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER Mansfield Scientific, Inc. LIT Class II 1985-07-19
K851565 HOMEDICA CEMENTED ACETABULAR COMPONENT 6262 Howmedica Corp. DXQ Class II 1985-07-19
K851128 DIGITMATIC DM2 Medimatic JOM Class II 1985-07-19
K852431 SUPRIMA II MODEL 254-26 Intermedics, Inc. DXY Class III 1985-07-19
K851900 SEA MED DDD PACING SYSTEM ANALYZER Seamed Corp. DTC Class II 1985-07-19
K852432 SUPRIMA II MODEL 254-28 Intermedics, Inc. DXY Class III 1985-07-17
K852430 SUPRIMA II MODEL 253-23 Intermedics, Inc. DXY Class III 1985-07-17
K850077 MEDTRONIC 5311 PACING SYSTEM ANALYZER Medtronic Vascular DTC Class II 1985-07-16
K850822 CHRONOCOR V EXTERNAL PACER, MODEL 297A Seamed Corp. DTE Class II 1985-07-16
K851825 SCANLAN TUNNELER, SHEATH & TIP Scanlan Intl., Inc. DWS Class I 1985-07-12
K851426 ACCUCOM CARDIAC OUTPUT MONITOR Lawrence Medical Systems, Inc. DXK Class II 1985-07-12
K851637 SIRECUST 425, RESPECTIVELY SIRECUST 430 Siemens Medical Solutions USA, Inc. DQK Class II 1985-07-12
K851458 MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD Intermedics, Inc. DTD Class II 1985-07-11
K851834 MANAN GWI GUIDE WIRE INTRODUCER Manan Manufacturing Co., Inc. DWS Class I 1985-07-11
K851833 MANAN SELDINGER NEEDLE Manan Manufacturing Co., Inc. DWS Class I 1985-07-11
K851461 IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE Telectronics, Inc. DTB Class III 1985-07-11
K852236 MEDTRONIC MODEL 5867-1A Medtronic Vascular KFJ Class III 1985-07-11
K851077 CARDIAC COOLING JACKET Pat O. Daily KRI Class I 1985-07-11
K843731 KENZ 80Z MARK II Suzuken Co., Ltd. DSI Class II 1985-07-11
K851457 MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. DTD Class II 1985-07-11
K851832 NAMAN POTTS COURNAND NEEDLE Manan Manufacturing Co., Inc. DWS Class I 1985-07-11
K851415 BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) Medi-Sport Testing, Inc. DSB Class II 1985-07-08
K843533 CARDIAC EVENT RECORDER Cryo2 Corp. DRT Class II 1985-06-28
K851628 RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO Eaton Medical Group DXJ Class II 1985-06-27
K851400 SIRECUST 420 PATIENT DIALOG MONITOR Siemens Medical Solutions USA, Inc. DXJ Class II 1985-06-26
K850829 WIRE, GUIDE, CATHETER Lake Region Mfg., Inc. DQY Class II 1985-06-26
K851044 CARDIOSTAT 3 RECORDER Siemens Elema AB DPS Class II 1985-06-26
K850828 WIRE, GUIDE - MODIFICATION Lake Region Mfg., Inc. DQX Class II 1985-06-26
K850827 GUIDE, WIRE, ANGIOGRAPHIC Lake Region Mfg., Inc. DQX Class II 1985-06-26
K851626 SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE Eaton Medical Group DSF Class I 1985-06-26
K844252 MODEL 9300 TREND ANALYZING BIO-MONITOR SYS Medtronic Vascular DXN Class II 1985-06-26
K851633 CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL Eaton Medical Group DPS Class II 1985-06-26
K851376 VENOUS RESERVOIR BAG BMR-1600 American Bentley DTN Class II 1985-06-25
K851401 VENUOS RESERVOIR BAG BMR-1900 American Bentley DTN Class II 1985-06-25
K851152 MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR Cryomedics, Inc. DWS Class I 1985-06-24
K851057 LASERFLO BLOOD PERFUSION MONITOR 403 Tsi, Inc. DPW Class II 1985-06-24
K844593 CARDIOVASCULAR CUSTOM SURGICAL KIT Xanmed Corp. DYB Class II 1985-06-21
K851420 MULTICOR S, MODELS 330A/331A Cordis Corp. DXY Class III 1985-06-21
K834059 FUKUDA DENSHI EH-11 Fukuda Denshi USA, Inc. DXG Class II 1985-06-21
K845037 PERCUTANEOUS ANGIOGRAPHIC NEEDLES Mallinckrodt Critical Care DYB Class II 1985-06-21
K851948 MEDTRONIC MODEL 6404 Medtronic Vascular DYG Class II 1985-06-20
K851971 SERIES 7000/HOLTER RECORDER Pfizer, Inc. DSH Class II 1985-06-20
K852378 LIGHT REFLECTION RHEOGRAPHY Hemodynamics, Inc. DSB Class II 1985-06-20
K851080 GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE G V Medical, Inc. LIT Class II 1985-06-20
K851615 CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE Centrimed Corp. DTQ Class II 1985-06-19
K851613 CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER Centrimed Corp. KFM Class II 1985-06-19
K851140 TELEFLEX MEDICAL INTRODUCER NEEDLE Teleflexmedical, Inc. DWS Class I 1985-06-19
K851855 BIO MEDICUS BIO PUMP MODEL BP-90 Bio Medicus, Inc. KFM Class II 1985-06-19
K850015 POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER Polymed Laboratories DXE Class II 1985-06-19
K852123 WHOLEY HI-TORQUE GUIDE WIRES Advanced Cardiovascular Systems, Inc. DQX Class II 1985-06-19
K851890 MEDTRONIC 5064 Medtronic Vascular DTD Class II 1985-06-19
K851614 CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY Centrimed Corp. DTQ Class II 1985-06-19
K851574 MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T Advanced Cardiovascular Systems, Inc. DQX Class II 1985-06-19
K851289 COBE GAS FILTER Cobe Laboratories, Inc. KRI Class I 1985-06-19
K850791 MDI 2000 - PULSE GENERATOR Micromedical Devices, Inc. DRO Class II 1985-06-19
K844360 CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS Cordis Corp. DXY Class III 1985-06-18
K842349 AMBULATORY PH RECORDING DEVICE Clinical Data Instruments, Inc. DSH Class II 1985-06-14
K850830 SHARP DIGITAL BP MONITOR MB-371H Sharp Electronics Corp. DXN Class II 1985-06-13
K843273 DISPOS. PRESSURE KIT 1295K SERIES Hewlett-Packard Co. DRS Class II 1985-06-11
K852207 OXFORD VDT-40 DISPLAY TERMINAL Oxford Medilog, Inc. DSI Class II 1985-06-11
K833047 DOSIMETRIC RELEASE OF RAD. TUBING PAC American Bentley DWF Class II 1985-06-11
K851416 STANICOR GAMMA 333B/334A Cordis Corp. DXY Class III 1985-06-11
K851418 OMNI-ATRICOR MODEL 308A Cordis Corp. DXY Class III 1985-06-11
K852037 NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER Philips Park DXN Class II 1985-06-11
K851419 MULTICOR GAMMA 402 SERIES PACER Cordis Corp. DXY Class III 1985-06-11
K851417 MULTICOR GAMMA MODELS 336/337 Cordis Corp. DXY Class III 1985-06-11
K844815 CORDIS ELECTROPHYSIOLOGY STIMULATOR Cordis Corp. JOQ Class II 1985-06-11
K851402 LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE Medi-Tech, Inc. DXT Class II 1985-06-10
K844896 DEL MAR AVIONICS 8300 SECTOR IMAGER SYS Del Mar Avionics DXK Class II 1985-06-10
K852118 MANIFOLD CLAMPS Omser Sv., Inc. DTL Class II 1985-06-06
K842203 LITTMAN TYPE SH-6010, NURSE TYPE Cher Mel Corp. LDE Class I 1985-06-06
K843324 SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH Cher Mel Corp. LDE Class I 1985-06-06
K850619 BEDSIDE PATIENT MONITOR W/MODULES Midwest Analog & Digital, Inc. DRT Class II 1985-06-06
K842817 MODEL 78353B Hewlett-Packard Co. DRT Class II 1985-06-06
K843010 BP-800 Pollenex Associated Mills, Inc. DXN Class II 1985-05-29
K850627 SPACELABS-GENERAL SYSTEM LINK Spacelabs, Inc. DQK Class II 1985-05-28
K844116 CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC Critikon Company, LLC DXG Class II 1985-05-28
K843580 MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO Graphic Controls Corp. DRS Class II 1985-05-28
K843055 ACCU-TRAC Olympic Medical Corp. DXN Class II 1985-05-28
K851325 MICROCOR ECG MONITOR Microcor, Inc. DRT Class II 1985-05-21
K842391 ACR 2500 CARDIOTOMY RESERVOIR FILTER Electromedics, Inc. DTN Class II 1985-05-21
K850917 ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN Sherwood Medical Co. DWF Class II 1985-05-21
K850925 BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER American Bentley DWF Class II 1985-05-21
K851665 PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE Pacesetter Systems DTD Class II 1985-05-21
K844854 OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT Vas-Cath of Canada , Ltd. DQO Class II 1985-05-21
K851699 COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE Cook Pacemaker Corp. DXY Class III 1985-05-16
K851088 UMI ANGIOGRAPHIC CATHETER Universal Medical Instrument Corp. DQO Class II 1985-05-16
K851004 CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX Gish Biomedical, Inc. DTP Class II 1985-05-16
K840445 SYNKARA Lectec Corp. DRX Class II 1985-05-16
K851141 TELEFLEX MEDICAL INTRODUCER CATHETER Teleflexmedical, Inc. DYB Class II 1985-05-16

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