meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
1998-07-01

Clearances · page 109 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K980087 PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 Pressure Products, Inc. DXC Class II 1998-07-01
K980362 MRI COMPATIBLE MONITOR AND ACCESSORIES Datex-Engstrom, Inc. DPS Class II 1998-06-30
K981906 MODIFICATION FOR PTA BALLOON CATHETER Cook, Inc. LIT Class II 1998-06-29
K973298 CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER Cardima, Inc. DQY Class II 1998-06-26
K965117 LIFE SUPPORT FOR TRAUMA AND TRANSPORT Northrop Grumman Corp. MKJ Class III 1998-06-26
K974178 PASSPORT 5L-CE MODEL 0998-00-0131XXX Datascope Corp. DRT Class II 1998-06-26
K980728 FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM Fukuda Denshi USA, Inc. DSI Class II 1998-06-19
K973013 OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER Vas-Cath, Inc. LIT Class II 1998-06-19
K980002 KOALA VASCULAR CLAMPS AND INSERTS Boss Instruments, Ltd. DXC Class II 1998-06-18
K974473 EASY RIDER MICRO CATHETER Micro Therapeutics, Inc. KRA Class II 1998-06-17
K980144 HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER Aerotel, Ltd. DXH Class II 1998-06-16
K974769 COSGROVE CLAMP Allegiance Healthcare Corp. DXC Class II 1998-06-12
K980971 BODYSTAT DUALSCAN 2005 Bodystat , Ltd. MNW Class II 1998-06-11
K964153 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000 Rossmax International , Ltd. DXN Class II 1998-06-11
K970668 THE AMPLANTZ GOOSE NECK MICROSNARE Microvena Corp. DQY Class II 1998-06-10
K980957 KAPLAN-SIMPSON INFUSASLEEVE II Localmed, Inc. QEY Class II 1998-06-10
K974292 NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES Nihon Kohden America, Inc. DQA Class II 1998-06-08
K980882 SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR Siemens Medical Solutions USA, Inc. DSI Class II 1998-06-05
K970689 IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U Arrow Intl., Inc. DSP Class II 1998-06-04
K974914 SHELHIGH NO-REACT PERICARDIAL PATCHES Shelhigh, Inc. DXZ Class II 1998-06-03
K980850 BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS C.R. Bard, Inc. DSP Class II 1998-06-03
K974792 CS/3(TM) MONITORS* Datex-Engstrom, Inc. DSI Class II 1998-06-02
K974812 COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR Cobe Cardiovascular, Inc. DTZ Class II 1998-06-01
K980780 DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES Datascope Corp. DSP Class II 1998-05-29
K972502 SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 Spacelabs Medical, Inc. DSI Class II 1998-05-28
K974285 PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT Perimed, Inc. DPW Class II 1998-05-28
K980961 CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. Cordis Webster, Inc. DRF Class II 1998-05-28
K973360 MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD Medtronic Vascular LDF Class II 1998-05-26
K973840 FAST-CATH (TM) INTRA-CARDIAC INTRODUCER Daig Corp. DYB Class II 1998-05-21
K981407 OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER Cordis Corp. LIT Class II 1998-05-20
K980625 SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG) Siemens Medical Solutions USA, Inc. DSI Class II 1998-05-19
K974080 CRITIKON SOFT BLOOD PRESSURE CUFF Johnson & Johnson Medical, Inc. DXQ Class II 1998-05-18
K980575 SITESEER ANGIOGRAPHIC CATHETER C.R. Bard, Inc. DQO Class II 1998-05-15
K980732 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT 3M Healthcare DRY Class II 1998-05-15
K971421 BARD ISOFLOW BLOOD PUMP C.R. Bard, Inc. DWA Class II 1998-05-14
K980935 CAPIOX SX HARDSHELL RESERVOIR Terumo Medical Corp. DTN Class II 1998-05-14
K981413 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. DQY Class II 1998-05-13
K980857 MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE Graphic Controls Corp. MKJ Class III 1998-05-12
K974560 CORDIS VANGUARD STEERABLE GUIDEWIRES Cordis Corp. DQX Class II 1998-05-11
K980624 CARDIOSTATION Universal Medical, Inc. DXH Class II 1998-05-11
K981079 VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT Impra, Inc. DSY Class II 1998-05-07
K981076 VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT Impra, Inc. DYF Class II 1998-05-07
K972020 OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR Cas Medical Systems, Inc. DXW Class II 1998-05-05
K980456 JOBST ATHROMBIC PUMP SYSTEM 2600 Jobst A Beiersdorf Co. JOW Class II 1998-05-05
K980385 DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES Datascope Corp. DSP Class II 1998-05-01
K970098 E100 SERIES SPO2 SENSORS Epic Medical Equipment Services, Inc. DQA Class II 1998-04-30
K980383 MOOORLDI LASER DOPPLER IMAGER Moor Instruments, Ltd. DPT Class II 1998-04-30
K970139 MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO Micro Weiss Electronics DPW Class II 1998-04-30
K970211 MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR Micro Weiss Electronics DPW Class II 1998-04-30
K980534 DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H The Heart Valve Div. Medtronic Cardiovascular Surg KRH Class II 1998-04-30
K980360 SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES Scimed Life Systems, Inc. DQX Class II 1998-04-29
K972996 EASY ECG PC BASED ELECTROCARDIOGRAPH Ates Medical S.R.L. DPS Class II 1998-04-28
K973237 CSS-CARDIOPLEGIA SAFETY SYSTEM Medtronic Bio-Medicus, Inc. DWB Class II 1998-04-27
K980282 URESIL DILATOR WITH RADIOPAQUE MARKER Uresil Corp. DRE Class II 1998-04-24
K972793 PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE Radi Medical Systems AB DQX Class II 1998-04-24
K980299 APEX OXIMETER Marquette Medical Systems, Inc. DQA Class II 1998-04-24
K980294 ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. DQX Class II 1998-04-24
K974747 CS/3 ARRHYTHMIA WORKSTATION Datex-Engstrom, Inc. DSI Class II 1998-04-23
K980898 FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER Radi Medical Systems AB DXC Class II 1998-04-21
K971504 HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER J-Lloyd Medical, Inc. DRF Class II 1998-04-20
K973639 ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. J-Lloyd Medical, Inc. DRF Class II 1998-04-20
K972800 PTA BALLOON CATHETER Cook, Inc. LIT Class II 1998-04-16
K973613 CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER Foley & Lardner DXN Class II 1998-04-14
K974510 ENVOY PATIENT MONITOR Mennen Medical, Inc. DSI Class II 1998-04-14
K972201 PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE Sulzer Carbomedics, Inc. DXZ Class II 1998-04-14
K980104 FLOW RIDER FLOW DIRECTED MICRO CATHETER Micro Therapeutics, Inc. KRA Class II 1998-04-10
K980503 TEMPORARY CARDIAC PACING WIRE ETHICON, Inc. LDF Class II 1998-04-10
K971726 CV PERI-GUARD - CARDIOVASCULAR PATCH Bio-Vascular, Inc. DXZ Class II 1998-04-10
K963703 ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) International Biophysics Corp. DPT Class II 1998-04-08
K964205 BETTER-TUBING Circulatory Technology, Inc. DWF Class II 1998-04-08
K974745 MANAN GWI GUIDE WIRE INTRODUCER Medical Device Technologies, Inc. DRC Class II 1998-04-06
K974743 MANAN Medical Device Technologies, Inc. DRC Class II 1998-04-06
K974742 MANAN POTTS-COURNAND NEEDLE Medical Device Technologies, Inc. DRC Class II 1998-04-06
K973334 OZ POWER SYRINGE Cardiovascular Innovations DXT Class II 1998-04-03
K973563 BIPORE BALLOON DILATATION CATHETER Bipore, Inc. LIT Class II 1998-04-01
K974351 BIOLOG 3000 ELECTROCARDIOGRAPH Micromedical, Inc. DPS Class II 1998-04-01
K972993 CHASE FEMORAL ACCESS CANNULATION SET Chase Medical, Inc. DWF Class II 1998-03-31
K973527 CARDIO-PAGER SYSTEM Data Critical Corp. MSX Class II 1998-03-31
K980806 AFFINITY MEDICAL PATIENT CABLE SYSTEM Affinity Medical Technologies, LLC DSA Class II 1998-03-25
K980714 BCI 3401 HANDHELD PULSE OXIMETER Bci Intl., Inc. DQA Class II 1998-03-25
K971910 MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) Hewlett-Packard GmbH DSI Class II 1998-03-23
K980119 ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE Guidant Corp. DQX Class II 1998-03-20
K980824 A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc. DXN Class II 1998-03-19
K974725 BIOZ.COM SYSTEM Cardiodynamics International Corp. DSB Class II 1998-03-18
K974746 M1765A ECG MANAGER Hewlett-Packard Co. DPS Class II 1998-03-18
K971314 DCAT EMBOLECTOMY CATHETER SYSTEM AngioDynamics, Inc. DXE Class II 1998-03-17
K980582 MULTI-LINK CABLE AND LEAD WIRE SYSTEMS Marquette Medical Systems, Inc. DSA Class II 1998-03-16
K972241 ZOLL REVIVER Zoll Medical Corp MKJ Class III 1998-03-16
K972213 MS-700 Alan S. Lee DPW Class II 1998-03-13
K974640 COAXIAL DILATOR SET Boston Scientific Corp DRE Class II 1998-03-13
K973061 CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) Citizen Watch Co., Ltd. DXN Class II 1998-03-13
K974773 HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC Guidant Corp. DQX Class II 1998-03-13
K973474 WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS Witt Biomedical Corporation MHX Class II 1998-03-13
K973640 TS2000 MEDICAL DEVICE MONITOR Trincore Systems, Inc. MSX Class II 1998-03-12
K972777 TEMPORARY OCCLUSION BALLOON SYSTEM Percu Surge, Inc. MJN Class II 1998-03-11
K974697 REUSABLE FINGER SENSOR 3444 Bci Intl., Inc. DQH Class II 1998-03-11
K972603 ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B Dr. Lee Co., Ltd. DPS Class II 1998-03-11
K972511 AMPLATZ GOOSE NECK SNARE KIT/ CATHETER Microvena Corp. DXE Class II 1998-03-06
K971840 OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM Invivo Research, Inc. MHX Class II 1998-03-04
K972500 TIR/TIJ AND POLYROX Biotronik, Inc. DTB Class III 1998-03-04

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