meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
48
Latest Decision
2015-02-18

Clearances · page 43 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K140045 BODY COMPOSITION ANALYZER Jawon Medical Co., Ltd. MNW Class II 2015-02-18
K142476 Master Caution Device MCD Healthwatch , Ltd. DXH Class II 2015-02-17
K141946 DIGITAL ELECTROCARDIOGRAPH Shenzhen Biocare Bio-Medical Equipment Co., Ltd. DPS Class II 2015-02-13
K134046 FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR Fukuda Denshi USA, Inc. MHX Class II 2015-02-12
K143072 ENROUTE Transcarotid Neuroprotection System Silk Road Medical, Inc. NTE Class II 2015-02-09
K142832 Unimed Disposable and Reusable SPO2 Sensors Unimed Medical Supplies, Inc. DQA Class II 2015-02-06
K141492 ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) Eurosets S.R.L DTZ Class II 2015-02-06
K142244 CLEO PATIENT MONITOR Infinium Medical MWI Class II 2015-02-06
K141963 12SL ECG ANALYSIS PROGRAM Ge Medical Systems Information Technologies, Inc. MHX Class II 2015-02-05
K141516 MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE Micro Therapeutics, Inc. d/b/a ev3 Neurovascular NRY Class II 2015-02-05
K143563 Infusion Aspiration Catheter System Inari Medical, Inc. QEW Class II 2015-02-03
K142459 Ebony PTA 0.014 RX Peripheral Dilatation Catheter Natec Medical , Ltd. LIT Class II 2015-02-03
K141354 NAVAJO PTA BALLOON DILATATION CATHETER Curative Medical, Inc. DQY Class II 2015-01-30
K141751 ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR Asahi Intecc Co., Ltd. MOF Class II 2015-01-30
K140852 VECTRAPLEX CMS Vectracor, Inc. MSX Class II 2015-01-30
K134051 TRANSONIC ELSA SYSTEM Transonic Systems, Inc. DXG Class II 2015-01-29
K142500 One Way Soft Valve Terumo Cardiovascular Systems Corporation MJJ Class II 2015-01-29
K142743 AliveCor Heart Monitor AliveCor, Inc. DXH Class II 2015-01-27
K141685 CROC Combat Medical Systems, LLC DXC Class II 2015-01-26
K142321 Benchmark Intracranial Access System Penumbra, Inc. DQY Class II 2015-01-26
K133659 HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING Philips Medical Systems MKJ Class III 2015-01-23
K143751 Visi Mobile Monitoring System Sotera Wireless, Inc. MWI Class II 2015-01-23
K133985 DIGITAL ELECTROCARDIOGRAPH Shenzhen Biocare Bio-Medical Equipment Co., Ltd. DPS Class II 2015-01-22
K142932 Deltex Medical KDP72 Doppler Probe Deltex Medical Limited DPT Class II 2015-01-22
K141707 ULTRASKIN HYDROPHILIC GUIDE WIRE Lepu Medical Technology (Beijing) Co., Ltd. DQX Class II 2015-01-21
K143317 Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) Currie Medical Specialties, Inc. JOW Class II 2015-01-20
K142106 DECISIO HEALTH PATIENT DASHBOARD Decisio Health, Inc. MWI Class II 2015-01-18
K142749 TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC DXO Class II 2015-01-18
K143166 Medline ReNewal Reprocessed Compression Limb Sleeves Surgical Instrument Service and Savings (Dba Medline Renewal JOW Class II 2015-01-16
K142209 Pulse oximeter NBM-200 Orsense, Ltd. DQA Class II 2015-01-16
K133239 ZOLL E SERIES Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2015-01-16
K142935 CareEvent Philips Medical Systems MSX Class II 2015-01-15
K143587 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire Boston Scientific Corporation DQX Class II 2015-01-15
K141070 SUPER SHEATH Togo Medikit Co., Ltd. DRE Class II 2015-01-15
K143412 ADROIT Guiding Catheter Cordis Corporation DQY Class II 2015-01-14
K141024 EXTERNAL PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2015-01-13
K143522 Presto Inflation Device C.R. Bard, Inc. MAV Class II 2015-01-12
K143588 Surefire Infusion System 021 Surefire Medical, Inc. DQO Class II 2015-01-12
K141441 MENNTOR X7 Mennen Medical , Ltd. DSI Class II 2015-01-09
K133130 BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER Cook, Inc. DQO Class II 2015-01-09
K141465 CARDIOGARD EMBOLI PROTECTION CANNULA Cardiogard Medical, Ltd. DWF Class II 2015-01-09
K143481 IntellaMap Orion High Resolution Mapping Catheter Rhythmia Medical, Inc. DRF Class II 2015-01-08
K141275 ENDOPHYS PRESSURE SENSING SHEATH KIT Endophys, Inc. DYB Class II 2015-01-07
K141615 ENDOPHYS BLOOD PRESSURE MONITOR Endophys, Inc. DSK Class II 2015-01-07
K142447 PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch Synovis Life Technologies, Inc. DXZ Class II 2015-01-07
K142840 Unity Network ID GE Healthcare MWI Class II 2015-01-07
K143107 DLP Vein Graft Cannula Medtronic, Inc. DWF Class II 2015-01-07
K143195 Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. MHX Class II 2014-12-22
K143067 Carnation Ambulatory Monitor Bardy Diagnostics, Inc. DSH Class II 2014-12-22
K143429 Passage Hemostasis Valve Merit Medical Systems, Inc. DTL Class II 2014-12-22
K142968 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co., Ltd. DXN Class II 2014-12-19
K132407 VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) Lifewatch Technologies , Ltd. DSI Class II 2014-12-19
K142356 Connex Spot Monitor,901058 Vital Signs Monitor Core Welch Allyn, Inc. MWI Class II 2014-12-19
K141969 FIRSTSTIC N INTRODUCER Argon Medical Devices, Inc. DYB Class II 2014-12-19
K142430 LIFEPAK 15 monitor/defibrillator Physio-Control, Inc. MKJ Class III 2014-12-19
K143328 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip Volcano Atheromed, Inc. MCW Class II 2014-12-19
K142901 RhythmView Workstation Topera, Inc. DQK Class II 2014-12-19
K142415 Hi-Torque JET Guide Wire Family Abbott Vascular, Inc. DQX Class II 2014-12-19
DEN140009 AMIGO REMOTE CATHETER SYSTEM Catheter Robotics, Inc. PJB Class II 2014-12-18
K142239 CPS Direct MediGuide Enabled outer catheter St Jude Medical DQY Class II 2014-12-18
K141218 ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM Vadiswire Corporation DQX Class II 2014-12-18
K141530 VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS Stereotaxis, Inc. DXX Class II 2014-12-18
K142702 Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad Medivance, Inc. DWJ Class II 2014-12-18
K142235 CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter St Jude Medical DQY Class II 2014-12-18
K140793 NANOSTIM INTRODUCER KIT St. Jude Medical, Inc. DYB Class II 2014-12-17
K142051 PRELUDE PLASTIC JACKETED GUIDE WIRE Merit Medical Systems, Inc. DQX Class II 2014-12-17
K140536 HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE Lake Region Medical DQX Class II 2014-12-17
K141295 MERIT HYDROPHILIC GUIDEWIRE Merit Medical Systems, Inc. DQX Class II 2014-12-16
K142772 Phlebo Press DVT 603 Mego Afek AC , Ltd. JOW Class II 2014-12-16
K141756 INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION Draeger Medical Systems, Inc. MSX Class II 2014-12-12
K142180 TELESENSE Scottcare Corporation DSI Class II 2014-12-12
K133795 SUMMED INFLATION DEVICE KIT Sunny Medical Device (Shenzhen) Co., Ltd. MAV Class II 2014-12-12
K142081 CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES Osprey Medical, Inc. DXT Class II 2014-12-12
K142607 AngioVac Circuit Angiodynamics DWE Class II 2014-12-11
K141054 DISTAL ACCESS TORQUE DEVICE Distal Access, LLC DQX Class II 2014-12-10
K143208 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit C.R. Bard, Inc. DTK Class II 2014-12-09
K141795 BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 R & D Batteries, Inc. MKJ Class III 2014-12-08
K142379 Passeo-35 PTA Catheter Biotronik, Inc. LIT Class II 2014-12-05
K140847 CARDIOSPY ECG HOLTER SYSTEMS Labtech Kft. MLO Class II 2014-12-05
K141064 VESOFLOW PLUS DVT COMPRESSION DEVICE Caremed Supply, Inc. JOW Class II 2014-12-04
K142728 ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) Medical Compressions System (Dbn) , Ltd. JOW Class II 2014-12-04
K141105 PULSE OXIMETER Hunan Accurate Bio-Medical Technology Co., Ltd. DQA Class II 2014-12-04
K142122 RADAR VASCULAR COMPRESSION DEVICE Advanced Vascular Dynamics DXC Class II 2014-12-04
K142288 MAC 800 Resting ECG Analysis System Ge Medical Systems China Co., Ltd. DPS Class II 2014-12-03
K142915 ZOLL X Series ZOLL Medical Corporation MKJ Class III 2014-12-03
K141020 SURVEYOR S4 MOBILE MONITOR Mortara Instrument, Inc. DRG Class II 2014-12-03
K141529 ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S DQY Class II 2014-12-03
K142672 AliveCor Heart Monitor AliveCor, Inc. DXH Class II 2014-12-03
K143057 M3290B Philips IntelliVue Information Center iX Philips Medical Systems MSX Class II 2014-12-03
K133924 ENDOLUMINAL OCCLUSION SYSTEM (EOS) Artventive Medical Group, Inc. KRD Class II 2014-12-03
K140296 CLEARLUMEN THROMBECTOMY SYSTEM Walk Vascular, LLC QEZ Class II 2014-12-02
K140796 MEDUSA VASCULAR PLUG, Endoshape, Inc. KRD Class II 2014-12-02
K142803 Skintact, various other tradenames Leonhard Lang GmbH MKJ Class III 2014-12-02
K133994 SIVR56-T KIT Barco N.V. DXJ Class II 2014-12-01
K142917 BP652N (HEM-6300-Z) Omron Healthcare, Inc. DXN Class II 2014-12-01
DEN130045 HEARTFLOW FFRCT Heartflow PJA Class II 2014-11-26
K141792 GENESIS TOUCH SYSTEM Honeywell Hommed DRG Class II 2014-11-25
K142393 PREDICATE III GUIDEWIRE Lake Region Medical DQX Class II 2014-11-25
K142394 Masimo Root Monitoring System and Accesories Masimo Corporation MWI Class II 2014-11-25
K140768 TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT Lepu Medical Technology (Bejing) Co., Ltd. DYB Class II 2014-11-25

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