meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2010-05-11

Clearances · page 63 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K101264 TEMPUS IC PROFESSIONAL PATIENT MONITOR Remote Diagnostic Technologies , Ltd. MWI Class II 2010-05-11
K093268 INTELLIVUE PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2010-05-11
K100274 MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L Medtronic, Inc. DWF Class II 2010-05-10
K093327 INTCO TAB ELECTRODE Shanghai Intco Electrode Manufacturing Co., Ltd. DRX Class II 2010-05-10
K093813 OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE Imbiotechnologies KRD Class II 2010-05-10
K101078 BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM Bl Healthcare, Inc. DRG Class II 2010-05-10
K093766 VITALOGIK 6000/6500 Mennen Medical , Ltd. DSI Class II 2010-05-07
K101067 SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 Philips Medical Systems MHX Class II 2010-05-07
K093739 BLOOD PRESSURE MONITOR/ MODELS Ningbo Diaier Electronic Co., Ltd. DXN Class II 2010-05-07
K092097 A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH A.B. Korkor Medical, Inc. DYB Class II 2010-05-06
K100508 CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B Carematix, Inc. DRG Class II 2010-05-05
K100306 KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES Covidien JOW Class II 2010-05-04
K100523 ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA Hygia Health Services, Inc. NMD Class II 2010-05-04
K100915 INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 Hutchinson Technology, Inc. MUD Class II 2010-04-30
K100930 PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J Volcano Corporation DQX Class II 2010-04-30
K100921 ADMIRAL XTREME PTA BALLOON DILATATION CATHETER Invatec S.P.A. LIT Class II 2010-04-30
K100278 QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA Maquet Cardiopulmonary, AG DTZ Class II 2010-04-30
K100939 INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2010-04-30
K100093 VSI TORQUE DEVICE Vascular Solutions, Inc. DQX Class II 2010-04-30
K093017 STELLAR 300 Larsen & Toubro Limited MWI Class II 2010-04-29
K100266 ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 Camntech, Ltd. MWJ Class II 2010-04-29
K093422 VITAL SYNC MODEL 5000 SERIES Somanetics Corp. MWI Class II 2010-04-29
K100710 ROLL-X GUIDEWIRE St Jude Medical DQX Class II 2010-04-28
K100319 MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L Merit Medical Systems, Inc. DTL Class II 2010-04-28
K100315 12 LEAD GLOVE I Needmd, Inc. DRX Class II 2010-04-23
K093977 ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX Chestnut Medical Technologies, Inc. DQY Class II 2010-04-22
K100470 GTX 12 GIDEWIRE Medtronic, Inc. DQX Class II 2010-04-21
K100789 MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST Evalve, Inc. DRA Class II 2010-04-21
K100383 VITAPHONE. MODEL 100 BT Vitasystems GmbH DXH Class II 2010-04-20
K100155 TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM Biomedical Systems Corp. DSI Class II 2010-04-20
K093431 CLEARWAY OTW MODEL 85912 Atrium Medical Corp. DQY Class II 2010-04-20
K100663 CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 Boston Scientific Corporation NAJ Class II 2010-04-16
K100135 GDS-DC12 Guided Delivery Systems DQY Class II 2010-04-16
K100127 ELI 230 ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2010-04-16
K100745 LIFEBED NETWORK PATIENT VIGILANCE SYSTEM Hoana Medical, Inc. DRT Class II 2010-04-15
K100394 MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A Shanghai 3f Electronics Co, Ltd. MWI Class II 2010-04-15
K100362 CAMBRIDGE HEART OEM Cambridge Heart, Inc. DQK Class II 2010-04-14
K093907 WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE Welch Allyn, Inc. DXN Class II 2010-04-14
K100272 INTELLIVUE CLINICAL INFORMATION PORTFOLIO Philips Medical Systems DXJ Class II 2010-04-14
K093554 RETROFLEX DILATOR KIT Edwards Lifesciences, LLC DRE Class II 2010-04-13
K100892 RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX Boston Scientific Corp KRA Class II 2010-04-12
K093802 ULTRAVIEW DM3 MONITOR Zoe Medical, Inc. DXN Class II 2010-04-09
K093288 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION Cardionet, Inc. QYX Class II 2010-04-08
K100046 M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 Guangdong Biolight Meditech Co., Ltd. MHX Class II 2010-04-08
K092785 COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 Vasomedical, Inc. DSH Class II 2010-04-02
K093858 PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A St. Jude Medical, Cardiac Rhythm Management Divisi DSA Class II 2010-04-02
K093205 PADCHECK Padtest, LLC DXN Class II 2010-04-01
K092391 MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED Concord Medical Products MKJ Class III 2010-04-01
K093869 SE-601 SERIES ELECTROCARDIOGRAPH Edan Instruments, Inc. DPS Class II 2010-04-01
K093872 HANDHELD ECG MONITOR, MODEL MD100 Beijing Choice Electronic Technololgy Co., Ltd. DPS Class II 2010-03-31
K093016 VITAL SIGNS MONITOR Shenzhen Creative Industry Co., Ltd. DQA Class II 2010-03-30
K100615 ARSTASIS ACCESS SYSTEM Arstasis, Inc. DYB Class II 2010-03-30
K093257 TORQMAX SHEATH GRIP ACCESSORY Spectranetics Corp. OFC Class II 2010-03-26
K092061 FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 Genexel Medical Instrument, Inc. DXN Class II 2010-03-26
K093831 FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT Health & Life Co., Ltd. DXN Class II 2010-03-25
K093976 RAISIN PERSONAL MONITOR Proteus Biomedical, Inc. DXH Class II 2010-03-25
K100507 XRES BLOOD COLLECTION RESERVOIR Sorin Group Italia S.R.L. DTN Class II 2010-03-24
K090364 EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE Angioslide, Ltd. LIT Class II 2010-03-23
K094044 SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT Tayside Flow Technologies Limited DSY Class II 2010-03-23
K100303 ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY Angioscore, Inc. PNO Class II 2010-03-22
K093791 GORE DRYSEAL SHEATH W. L. Gore & Associates, Inc. DYB Class II 2010-03-22
K091564 NBM-200MP PULSE OXIMETRY DEVICE Orsense, Ltd. DQA Class II 2010-03-19
K093934 GORE HYBRID VASCULAR GRAFT W.L. Gore & Associates DSY Class II 2010-03-17
K093965 ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS C.R. Bard, Inc. LIT Class II 2010-03-17
K092558 WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES Harvard Medical Devices , Ltd. DXN Class II 2010-03-17
K100351 NEUROSCOUT STEERABLE GUIDEWIRE Codman & Shurtleff, Inc. DQX Class II 2010-03-16
K100490 LITEPAC, MODEL 682 ClearStream Technologies , Ltd. LIT Class II 2010-03-16
K093232 OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER Great Batch Medical DYB Class II 2010-03-15
K092950 SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES Solaris Medical Technology, Inc. DQA Class II 2010-03-12
K093881 TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR GE Healthcare Finland Oy DQA Class II 2010-03-12
K092786 INBODY, MODELS: 270, R20, R20B Biospace Corporation Limited MNW Class II 2010-03-10
K093788 INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION Draeger Medical Systems, Inc. MHX Class II 2010-03-08
K100020 DX SERIES FINGER SENSOR Dixtal Medical, Inc. DQA Class II 2010-03-08
K100446 CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE Devon Medical, Inc. JOW Class II 2010-03-05
K093969 ACUITY BREAK-AWAY GUIDE CATHETER Cardiac Pacemakers, Inc. DQY Class II 2010-03-05
K093306 SINGLE-PATIENT USE DISPOSABLE SENSOR Nonin Medical, Inc. DQA Class II 2010-03-04
K091732 VRLXP, MODEL XP Deep Breeze , Ltd. OCR Class II 2010-03-04
K093757 MD300C1 FINGERTIP PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2010-03-03
K091634 NMI FC Navilyst Medical, Inc. DTL Class II 2010-03-01
K092947 TELESENTRY, MODEL TS01 Scottcare Corporation DSI Class II 2010-02-26
K092965 TRAILRUNNER GUIDEWIRES Lake Region Mfg., Inc. DQX Class II 2010-02-26
K091188 ASAHI ZENYTEEX GUIDING CATHETER Asahi Intecc Co., Ltd. DQY Class II 2010-02-26
K091006 ITG VASCULAR ACCESS SYSTEM, MODEL 300 Arstasis, Inc. DYB Class II 2010-02-25
K093942 ENSITE VELOCITY SYSTEM V1.3 St Jude Medical DQK Class II 2010-02-25
K093026 FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER Footprint Medical DYB Class II 2010-02-24
K093647 TRAXCESS DOCKING WIRE MicroVention, Inc. DQX Class II 2010-02-24
K092369 12SL ECG ANALYSIS PROGRAM Ge Medical Systems Information Technologies MHX Class II 2010-02-24
K093339 ELI PC ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2010-02-19
K091029 CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) Rex Medical MCW Class II 2010-02-18
K093650 BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM Medtronic, Inc. DTY Class II 2010-02-17
K092175 THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 Flowcardia, Inc. PDU Class II 2010-02-17
K093824 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT Health & Life Co., Ltd. DXN Class II 2010-02-16
K093515 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON Brivant, Ltd. DQX Class II 2010-02-16
K094019 GLIDER PTA BALLOON CATHETER Trireme Medical, Inc. DQY Class II 2010-02-12
K093192 FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE Advanced Vascular Dynamics JOM Class II 2010-02-12
K093004 IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING Merit Medical Systems, Inc. DQO Class II 2010-02-12
K093476 AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 Aga Medical Corp. DQY Class II 2010-02-05
K091077 OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER Cordis Corp., A Johnson & Johnson Co. DTK Class II 2010-02-04
K100063 HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL Ev3, Inc. MJN Class II 2010-02-02
K092970 GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H General Meditech, Inc. MHX Class II 2010-02-02

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