meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
48
Latest Decision
2016-02-23

Clearances · page 39 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K152160 Navik 3D Apn Health, LLC DQK Class II 2016-02-23
K152831 Spot Skan Skanray Technologies Private Limited DXN Class II 2016-02-23
K142969 ANI Monitor Mdoloris Medical Systems Sas DPS Class II 2016-02-23
K151520 Oscar 2 Suntech Medical, Inc. DXN Class II 2016-02-19
K152902 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2016-02-18
K152136 Recovery Cone Removal System C.R. Bard, Inc. MMX Class II 2016-02-18
K151258 Arm automatic blood pressure monitor Shenzhen Pump Medical System Co., Ltd. DXN Class II 2016-02-18
K153523 FUSION Vascular Graft Maquet Cardiovascular, LLC DSY Class II 2016-02-16
K152485 FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm Ostial Corporation LOX Class II 2016-02-16
K151512 Star 60 Skanray Technologies Private Limited MWI Class II 2016-02-14
K153077 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH DXN Class II 2016-02-12
K152231 Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire Boston Scientific Corporation DQX Class II 2016-02-12
K151644 Masimo Root Vital Signs Monitoring System and Accessories Masimo Corporation MWI Class II 2016-02-12
K160092 Digital Electrocardiograph Shenzhen Biocare Bio-Medical Equipment Co., Ltd. DPS Class II 2016-02-12
K153246 PTFE Super Sheath Introducer 2.1 Medcomp (Medical Components, Inc.) DYB Class II 2016-02-12
K152991 OptoWire Deux Opsens DQX Class II 2016-02-11
K152645 Dictum Health Dictum Health, Inc. MWI Class II 2016-02-09
K151835 Vital Signs Patch System Lifewatch Technologies , Ltd. DSI Class II 2016-02-05
K153530 Bridge Occlusion Balloon Spectranetics, Inc. MJN Class II 2016-02-05
K152427 PC ECG Edan Instruments, Inc. DPS Class II 2016-02-05
K152127 CorMatrix Tyke Cormatrix Cardiovascular, Inc. DXZ Class II 2016-02-04
K153141 DyeVert Contrast Modulation System Osprey Medical, Inc. DXT Class II 2016-02-04
K160014 iHealth Track Blood Pressure Monitor Andon Health Co, Ltd. DXN Class II 2016-02-02
K153304 Hansen Medical Magellan Robotic Catheter eKit Hansen Medical, Inc. DRA Class II 2016-02-01
K153628 ROSC-U Mini Chest Compressor (RMCC) Resuscitation International, LLC DRM Class II 2016-01-30
K151787 Holter System Edan Instruments, Inc. DQK Class II 2016-01-27
K153729 8F FlowGate2 Balloon Guide Catheter Concentric Medical DQY Class II 2016-01-27
K151812 PATIENT MONITORS VARIOUS MODELS Philips Medical Systems MHX Class II 2016-01-26
K152456 CenterCross Ultra Catheter Roxwood Medical, Inc. DQY Class II 2016-01-26
K151048 CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set Bracco Injeneering IZQ Class II 2016-01-22
K151617 Livewire Electrophysiology Catheter Surgical Instrument Service and Savings Inc.(Dba Medline Ren NLH Class II 2016-01-22
K152873 Crosstella RX Balloon Dilatation Catheter KANEKA Corporation LIT Class II 2016-01-22
K152447 ASAHI Caravel Asahi Intecc Co., Ltd. DQY Class II 2016-01-22
K152497 PW Guidewires Tatara Vascular, LLC DQX Class II 2016-01-22
K152887 Crosperio RX PTA Balloon Dilatation Catheter KANEKA Corporation LIT Class II 2016-01-22
K152833 Pruitt F3-S Polyurethane Carotid Shunt LeMaitre Vascular, Inc. MJN Class II 2016-01-21
K153672 basixTOUCH40 Inflation Syringe Merit Medical Systems, Inc. MAV Class II 2016-01-20
K152613 True Flow Valvuloplasty Perfusion Catheter C.R. Bard, Inc. OZT Class II 2016-01-19
K152980 Flo Trac sensor, Volume View sensor Edwards Lifesciences, LLC DRS Class II 2016-01-19
K153598 Medtronic Bio-Medicus Adult Cannula Kit Medtronic, Inc. DWF Class II 2016-01-15
K151269 ECG Mini System Continuous ECG Monitor and Arrhythmia Detector Lifewatch Technologies , Ltd. DSI Class II 2016-01-15
K152450 Esophageal Cooling Device Advanced Cooling Therapy, LLC PLA Class II 2016-01-15
K151141 Cronus HP - High Pressure Peripheral Balloon Catheter Nipro Medical Corporation LIT Class II 2016-01-14
K152361 OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System Liebel-Flarsheim Company, LLC IZQ Class II 2016-01-14
K153125 IntraNovo Microcatheter Texasmedical Technologies, Inc. DQO Class II 2016-01-13
K152541 Penumbra System ACE 64 and ACE 68 Reperfusion Catheters Penumbra, Inc. NRY Class II 2016-01-13
K152733 FFRct HeartFlow, Inc. PJA Class II 2016-01-13
K152993 MUSE Cardiology Information System Ge Medical Systems Information Technologies, Inc. DQK Class II 2016-01-12
K153197 Fortress Introducer Sheath SYstem Contract Medical International, GmbH DYB Class II 2016-01-11
K152876 LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM Tni Manufacturing, Inc. DQY Class II 2016-01-08
K151960 Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Baoan Medical Supplies Co., Ltd. DXT Class II 2016-01-07
K153214 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co., Ltd. DXN Class II 2016-01-07
K153069 Edwards Balloon Catheter Edwards Lifesciences OMZ Class II 2016-01-07
K153259 VasoStat Hemostasis Device Forge Medical, Inc. DXC Class II 2016-01-06
K153502 ClariVein IC Vascular Insights, LLC KRA Class II 2016-01-06
K152944 Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems Mortara Instrument, Inc. DPS Class II 2016-01-06
K151287 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D Guangdong Biolight Meditech Co., Ltd. DQA Class II 2016-01-06
K152498 SoloPath Re-Collapsible Access System Onset Medical Corporation DYB Class II 2016-01-05
K153094 Visions PV .035 Digital IVUS Catheter Volcano Corporation OBJ Class II 2015-12-31
K153053 Traxcess Pro 14 Guidewire MicroVention, Inc. MOF Class II 2015-12-29
K152330 Expression MR400 MRI Patient Monitoring System Invivo Corporation MWI Class II 2015-12-23
K153071 Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular NRY Class II 2015-12-23
K150870 HydroPearl Microspheres, HydroPearl Microspheres MicroVention, Inc. KRD Class II 2015-12-21
K151672 Cerner CareAware Event Management Cerner Corporation MSX Class II 2015-12-21
K153210 Defibrillator Analyzer Variable Load Bc Group International, Inc. DRL Class II 2015-12-21
K152387 Fluent Inflation Device Vascular Solutions, Inc. MAV Class II 2015-12-18
K150964 MReye Flipper Detachable Embolization Coil and Delivery System Cook Incorporated KRD Class II 2015-12-18
K150931 MReye Embolization Coils Cook Incorporated KRD Class II 2015-12-18
K152150 V8 Balloon Aortic Valvuloplasty Catheter Intervalve, Inc. OZT Class II 2015-12-18
K151126 Foresight Intracardiac Echocardiography (ICE) System Colibri Technologies, Inc. DQO Class II 2015-12-18
K152384 Digital Electrocardiograph Shenzhen Biocare Bio-Medical Equipment Co., Ltd. DPS Class II 2015-12-18
K151810 Bpump Blood Pressure Cuff Shenzhen Pump Medical System Co., Ltd. DXQ Class II 2015-12-17
K152115 Renew NCP-5 External Counterpulsation System Stage 2 Innovations DRN Class II 2015-12-17
K152491 MoMe Software Platform Infobionic, Inc. DSI Class II 2015-12-17
K153376 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation DTQ Class II 2015-12-16
K153450 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH DXN Class II 2015-12-16
K150992 Vios Monitoring System Vios Medical, Inc. DRT Class II 2015-12-16
K150908 XM-01 Electronic Automatic Blood Pressure Monitor Sky Innovation Technology ( Shanghai) Limited DXN Class II 2015-12-16
K151840 Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire Boston Scientific Corporation DQX Class II 2015-12-16
K150806 PulseFlowDF Pulseflow Technologies JOW Class II 2015-12-16
K151063 Monitor B40 Ge Medical Systems China Co., Ltd. MHX Class II 2015-12-15
K152341 ViSi Mobile Monitoring System Sotera Wireless, Inc. MWI Class II 2015-12-14
K152202 Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm Tni Manufacturing, Inc. DQY Class II 2015-12-14
K150782 AbStats Gateway Gi Logic, Inc. DQD Class II 2015-12-14
K152157 LC Bead LUMI Biocompatibles UK , Ltd. KRD Class II 2015-12-11
K150869 Checkme Pro Health Monitor Viatom Technology Co., Ltd. MWI Class II 2015-12-10
K151158 ALP VasQcare Take Home System Currie Medical Specialties, Inc. JOW Class II 2015-12-10
K151396 MIVI Mi-AXUS Guide Catheter Mivi Neuroscience, Inc. DQY Class II 2015-12-09
K151127 higi Station Higi Sh, LLC DXN Class II 2015-12-08
K151896 Houdini Catheter Cruzar Medsystems, Inc. DQY Class II 2015-12-07
K152139 Vital Connect Platform, HealthPatch MD, VitalPatch Vitalconnect, Inc. DRG Class II 2015-12-06
K151936 Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle Synaptic Medical Limited DYB Class II 2015-12-04
K152401 Stingray LP Catheter Boston Scientific Corporation DQY Class II 2015-12-04
K152582 CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box Volcano Corporation DSK Class II 2015-12-03
K153213 Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir Terumo Cardiovascular Systems Corporation DTZ Class II 2015-12-03
K152528 Attachable Cath Lab Hemostasis Valve Galt Medical Corp. DTL Class II 2015-12-02
K153140 Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating Terumo Cardiovascular Systems Corp. DTZ Class II 2015-12-02
K152840 Lantern Delivery Microcatheter Penumbra, Inc. DQY Class II 2015-12-02
K153143 Capiox Advance Hardshell Reservoir Terumo Cardiovascular Systems Corporation DTN Class II 2015-12-02
K152173 Glidesheath Terumo Medical Corporation DYB Class II 2015-12-01

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