meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
49
Latest Decision
2009-08-20

Clearances · page 66 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K083747 TERUMO PALL AL3X ARTERIAL FILTER Terumo Cardiovascular Systems Corp. DTM Class II 2009-08-20
K091739 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 Andon Health Co, Ltd. DXN Class II 2009-08-18
K091737 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 Andon Health Co, Ltd. DXN Class II 2009-08-18
K091738 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD Andon Health Co, Ltd. DXN Class II 2009-08-18
K091408 DISPOSABLE PRESSURE TRANSDUCER Shenzhen Ant Hi-Tech Industrial Co., Ltd. DRS Class II 2009-08-18
K083382 CHROMA, MODEL: RZ153C Scottcare Corporation MWJ Class II 2009-08-13
K092315 SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR Sorin Group Italia S.R.L. DTN Class II 2009-08-12
K090662 MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP Masimo Corporation DQA Class II 2009-08-10
K092075 CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 St. Jude Medical, Cardiac Rhythm Management Divisi DQY Class II 2009-08-07
K092299 TRAILBLAZER SUPPORT CATHETER Ev3, Inc. DQY Class II 2009-08-07
K091856 CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES Conmed Corporation DRX Class II 2009-08-07
K091548 AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A Amco International Manufacturing & Design, Inc. MKJ Class III 2009-08-07
K092343 EN SNARE ENDOVASCULAR SNARE SYSTEM Merit Medical Systems, Inc. MMX Class II 2009-08-07
K091626 CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH Cryolife, Inc. DXZ Class II 2009-08-07
K091385 APPROACH HYDRO ST WIRE GUIDE, MODEL HMW Cook, Inc. DQX Class II 2009-08-07
K092064 SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 Biosense Webster, Inc. OBJ Class II 2009-08-07
K090493 SIGNAL Zargis Medical Corp. DQD Class II 2009-08-07
K091165 HORIZON XVU Mennen Medical , Ltd. DQK Class II 2009-08-07
K091062 MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 Gish Biomedical, Inc. DTN Class II 2009-08-04
K091500 MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 Andon Health Co, Ltd. DXN Class II 2009-07-31
K091491 HERO VASCULAR ACCESS DEVICE Hemosphere, Inc. DSY Class II 2009-07-31
K091997 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 Andon Health Co, Ltd. DXN Class II 2009-07-30
K091563 RECRUIT MICROCATHETER Reverse Medical Corporation MMX Class II 2009-07-30
K083131 MEDOS HILITE RESERVOIR, MODEL: 4030 Gish Biomedical, Inc. DTN Class II 2009-07-30
K091966 ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 Angioscore, Inc. PNO Class II 2009-07-30
K092045 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 Andon Health Co, Ltd. DXN Class II 2009-07-30
K090867 AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 Ep Dynamics, Inc. DYB Class II 2009-07-30
K083719 LNCS OXIMETRY SENSORS Masimo Corporation NLF Class II 2009-07-30
K091961 MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 Concentric Medical, Inc. DQO Class II 2009-07-30
K090918 NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER Nfocus Neuromedical, Inc. DQY Class II 2009-07-30
K091594 HEART-EXERCISE Ge Medical Systems Information Technologies GmbH MHX Class II 2009-07-29
K091054 WALK400H Et Medical Devices Spa MWJ Class II 2009-07-27
K090438 REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR Envitec-Wismar GmbH DQA Class II 2009-07-24
K091985 UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE Ivy Biomedical Systems, Inc. DRT Class II 2009-07-24
K081603 DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 Heartforce Medical, Inc. DXR Class II 2009-07-24
K091513 SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 Edan Instruments, Inc. DPS Class II 2009-07-24
K091075 ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM iRhythm Technologies, Inc. DQK Class II 2009-07-21
K090599 MD300K1 PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2009-07-20
K091021 MODIFICATION TO MEDICOMPASS CONNECT Imetrikus, Inc. DRG Class II 2009-07-15
K083903 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 3M Company DQD Class II 2009-07-15
K091834 PASSPORT V MONITOR, MODEL 0998-00-6100 Datascope Corp., Patient Monitoring Division MHX Class II 2009-07-15
K091008 STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 Sorin Group Deutschland GmbH DWA Class II 2009-07-15
K091908 M3 MONITOR Spectrum Medical , Ltd. DRY Class II 2009-07-10
K091224 OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S Somanetics Corp. MUD Class II 2009-07-09
K091700 AIRCAST VENAFLOW ELITE SYSTEM Djo, LLC JOW Class II 2009-07-09
K090165 RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 Masimo Corporation DQA Class II 2009-07-09
K091793 AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 Aga Medical Corp. DQY Class II 2009-07-09
K091057 MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES Masimo Corporation DQA Class II 2009-07-09
K091397 ECSCOPE 200 Dyansys, Inc. DPS Class II 2009-07-08
K091882 AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM MicroVention, Inc. KRD Class II 2009-07-08
K083094 STREAMER POLYMER GUIDEWIRE Brivant, Ltd. DQX Class II 2009-07-07
K090479 TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 Tanita Corporation of America MNW Class II 2009-07-07
K091596 EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST Evalve, Inc. DRA Class II 2009-07-02
K091007 AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 Sorin Group Deutschland GmbH DTQ Class II 2009-07-02
K090554 ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE Boston Scientific Corp DQX Class II 2009-07-02
K091304 VORTEX CANNULA Vortex Medical, Inc. DWF Class II 2009-07-02
K091299 SPECTRANETICS TURBO-TANDEM SYSTEM Spectranetics Corp. DQY Class II 2009-07-01
K090613 CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 St. Jude Medical, Cardiac Rhythm Management Divisi DQY Class II 2009-07-01
K090807 REGIONAL OXIMETER SYSTEM, MODEL 7600 Nonin Medical, Inc. MUD Class II 2009-06-30
K091593 ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS Possis Medical, Inc. QEZ Class II 2009-06-22
K083753 SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU K-Jump Health Co., Ltd. DXN Class II 2009-06-19
K091504 MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 Micrus Endovascular Corporation MJN Class II 2009-06-19
K090696 NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM Corventis, Inc. QYX Class II 2009-06-19
K090987 VASCUTEK BRANCHED GELWEAVE Vascutek, Ltd. DSY Class II 2009-06-19
K091509 JETSTREAM G2 NXT SYSTEM, MODEL PV20300 Pathway Medical Technologies, Inc. MCW Class II 2009-06-19
K090621 FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 Flowcardia, Inc. DXT Class II 2009-06-19
K090977 PIGGYBACK WIRE CONVERTER Vascular Solutions, Inc. DQY Class II 2009-06-18
K080941 BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM N.I. Medical, Ltd. DSB Class II 2009-06-18
K091449 DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 Datascope Corp., Cardiac Assist Division DSP Class II 2009-06-18
K090422 LUCAS 2 Jolife AB DRM Class II 2009-06-17
K090180 TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE Vermed, Inc. DRX Class II 2009-06-17
K081259 DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC MKJ Class III 2009-06-15
K091345 GOPHER GOLD CATHETER, MODEL 5620 Vascular Solutions, Inc. DQY Class II 2009-06-12
K090511 QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 Maquet Cardiopulmonary, AG DTZ Class II 2009-06-12
K091527 ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER Cook, Inc. DQY Class II 2009-06-12
K090970 FLOCONTROL , MODEL 1028 Coaxia, Inc. MJN Class II 2009-06-12
K090671 PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D Contec Medical System Co., Ltd. DQA Class II 2009-06-11
K083010 SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR Shenzhen Med-Link Electronics Tech Co., Ltd. DQA Class II 2009-06-10
K091505 COR12+ Viasys Healthcare GmbH DSH Class II 2009-06-10
K090698 CAPIOX BUBBLE TRAP WITH X-COATING Terumo Cardiovascular Systems KRL Class II 2009-06-08
K090443 PLANET 55, MODEL 100 Larsen & Toubro Limited MHX Class II 2009-06-05
K090172 STAR 55 MODEL 100 Larsen & Toubro Limited MHX Class II 2009-06-05
K091395 MP5 INTELLIVUE PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2009-06-05
K083862 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM Medapps, Inc. DRG Class II 2009-06-05
K091370 RADIA STEERABLE DIAGNOSTIC CATHETER C.R. Bard, Inc. DRF Class II 2009-06-05
K090114 MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S Oscor, Inc. DYB Class II 2009-06-04
K090771 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 Andon Health Co, Ltd. DXN Class II 2009-06-04
K090772 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 Andon Health Co, Ltd. DXN Class II 2009-06-04
K081410 OPTION VENA CAVA FILTER Rex Medical DTK Class II 2009-06-04
K090768 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, Andon Health Co, Ltd. DXN Class II 2009-06-04
K090770 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 Andon Health Co, Ltd. DXN Class II 2009-06-04
K090769 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 Andon Health Co, Ltd. DXN Class II 2009-06-04
K083336 LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL Smiths Medical Asd, Inc. DWJ Class II 2009-06-03
K090367 SE-601 SERIES ELECTROCARDIOGRAPH Edan Instruments, Inc. DPS Class II 2009-06-03
K081147 ISOFLOW INFUSION CATHETER Vascular Designs, Inc. KRA Class II 2009-05-29
K091329 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. DYB Class II 2009-05-29
K091254 THE CROSSER 14 OTW CATHETER, MODEL CRU014 Flowcardia, Inc. DQY Class II 2009-05-29
K090602 CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS Cardiodynamics International Corp. DSB Class II 2009-05-28
K091358 ECSCOPE 100 Dyansys, Inc. DPS Class II 2009-05-28
K091050 506CN PATIENT MONITOR Criticare Systems, Inc. DRT Class II 2009-05-27

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