meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
2015-11-24

Clearances · page 40 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K152225 Edwards eSheath Introducer Set Edwards Lifesciences DYB Class II 2015-11-24
K153102 QuadraSphere Microspheres Biosphere Medical, S.A. KRD Class II 2015-11-23
K152762 Fogarty Occlusion Catheter Edwards Lifesciences, LLC MJN Class II 2015-11-23
K153086 RX ACCUNET Embolic Protection System Abbott Vascular NTE Class II 2015-11-20
K152829 Visions PV.014P RX Digital IVUS Catheter Volcano Corporation OBJ Class II 2015-11-19
K151791 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir Terumo Cardiovascular Systems Corporation DTZ Class II 2015-11-19
K143310 MoisturemeterD Delfin Technologies, Ltd. OBH Class II 2015-11-19
K151234 R350 guidewire Vascular Solutions, Inc. DQX Class II 2015-11-18
K152740 Radifocus Glidewire Ashitaka Factory of Terumo Corp. DQX Class II 2015-11-16
K151825 Viradius Neurowire Mivi Neuroscience, Inc. MOF Class II 2015-11-16
K151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm Stryker DQY Class II 2015-11-13
K151638 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter Cathera, Inc. DQY Class II 2015-11-13
K152181 Turbo-Power Laser Atherectomy Catheter Spectranetics, Inc. MCW Class II 2015-11-12
K152525 TR BAND Radial Compression Device Terumo Medical Corporation DXC Class II 2015-11-10
K152426 Wrist - Type Fully Automatic Digital Blood Pressure Monitor Sejoy Electronics & Instruments Co., Ltd. DXN Class II 2015-11-09
K151713 LILLIPUP PMP, LILLIPUT PMP INTEGRATED Sorin Group Italia S.R.L. DTZ Class II 2015-11-06
K150268 CerOX Or-Nim Medical , Ltd. DPW Class II 2015-11-06
K151080 Nihon Kohden CSM 1901 Bedside Monitor Nihon Kohden MHX Class II 2015-11-05
K150329 elance Vital Signs Monitor, Central Monitor Software Spacelabs Healthcare MHX Class II 2015-11-05
K150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter Zoll Circulation, Inc. NCX Class II 2015-10-30
K152381 Prelude SNAP Splittable Hydrophilic Sheath Introducer Merit Medical Systems, Inc. DYB Class II 2015-10-30
K151366 Philips CS770 IntelliSpace Critical Care and Anesthesia Philips Medical Systems DXJ Class II 2015-10-30
K152605 Impulse Angiographic Catheter, Expo Angiographic Catheter Boston Scientific Corporation DQO Class II 2015-10-29
K152465 Disposable Blood Pressure Cuff Shenzhen Vistar Medical Supplies Co., Ltd. DXQ Class II 2015-10-29
K151715 T3 Software Etiometry, Inc. MWI Class II 2015-10-29
K152468 Reusable Blood Pressure Cuff Shenzhen Vistar Medical Supplies Co., Ltd. DXQ Class II 2015-10-29
K152124 Tempus IC2 Remote Diagnostics Technologies, Ltd. MWI Class II 2015-10-28
K152363 Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M Philips Medical Systems DXQ Class II 2015-10-27
K152801 ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT Statcorp Medical DXQ Class II 2015-10-27
K151865 PremiPatch PTFE Pledget Aesculap, Inc. DXZ Class II 2015-10-27
K152665 PolarCath Peripheral Dilatation System Nucyro Vascular, LLC LIT Class II 2015-10-26
K152560 Bard Snare Retrieval Kit Neometrics, Inc. MMX Class II 2015-10-23
K151821 ER-REBOA Catheter Pryor Medical Devices, Inc. DQY Class II 2015-10-23
K151911 WorkMate Claris System, WorkMate Claris System Display Plus St Jude Medical DQK Class II 2015-10-22
K152784 Pacel Bipolar Pacing Catheters St Jude Medical LDF Class II 2015-10-22
K150314 Masimo MightySat Rx Fingertip Pulse Oximeter Masimo Corporation DQA Class II 2015-10-22
K150902 330psi Extension Y-Line with Dual Check Valve Coeur, Inc. DXT Class II 2015-10-22
K151736 Philips IntelliVue GuardianSoftware Philips Medizin Systeme Boblingen GmbH DXJ Class II 2015-10-21
K152770 ProBP 2400 Digital Blood Pressure Device Microlife Intellectual Property GmbH DXN Class II 2015-10-21
K152694 Diamondback 360 Peripheral Orbital Atherectomy System Cardiovascular Systems, Inc. MCW Class II 2015-10-21
K151415 Oregon Scientific Idt Technology Limited DXN Class II 2015-10-21
K152693 CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels Boston Scientific Corporation DRQ Class II 2015-10-21
K152709 HI-TORQUE BALANCE Abbott Vascular DQX Class II 2015-10-21
K151389 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir Terumo Cardiovascular Systems Corporation DTZ Class II 2015-10-20
K150232 Radifocus Optitorque Angiographic Catheter Ashitaka Factory of Terumo Corp. DQO Class II 2015-10-19
K152687 Arm-Type Fully Automatic Digital Blood Pressure Monitor Sejoy Electronics & Instruments Co., Ltd. DXN Class II 2015-10-16
K151300 AVERT Contrast Modulation System Osprey Medical, Inc. DXT Class II 2015-10-15
K152633 Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe Edwards Lifesciences, LLC LDF Class II 2015-10-15
K152275 Pantheris System Avinger, Inc. MCW Class II 2015-10-14
K151724 AngioDynamics Mariner Angiographic Catheters AngioDynamics, Inc. DQO Class II 2015-10-14
K151746 Dyevert Contrast Modulation System Osprey Medical, Inc. DXT Class II 2015-10-09
K152550 MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM Medicalgorithmics S.A. DSI Class II 2015-10-08
K152240 Passeo-14 Peripheral Dilatation Catheter Biotronik, Inc. LIT Class II 2015-10-08
K151744 Passeo-18 Peripheral Dilation Catheter Biotronik, Inc. LIT Class II 2015-10-08
K151610 Comet Pressure Guidewire Boston Scientific Corporation DXO Class II 2015-10-06
K151613 iLab Polaris Multi-Modality Guidance System Boston Scientific Corporation DQK Class II 2015-10-06
K151027 zensor system Intelesens Limited MHX Class II 2015-10-02
K150892 CorPath 200 System Corindus, Inc. DXX Class II 2015-10-02
K152177 SonoStik IV Guide Wire Introducer Sonostik, LLC DYB Class II 2015-10-01
K152483 Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series Grandway Technology (Shenzhen) Limited DXN Class II 2015-09-29
K151761 SureSigns VS3, SureSigns VS4 Phillips Medical Systems DSJ Class II 2015-09-29
K151358 AZUR CX Detachable 35 Coils MicroVention, Inc. KRD Class II 2015-09-25
K150402 Endoluminal Occlusion System-EOS Artventive Medical Group, Inc. KRD Class II 2015-09-25
K152003 iHealth BP3L Wireless Blood Pressure Monitor Andon Health Co, Ltd. DXN Class II 2015-09-24
K152080 Metacross OTW PTA Balloon Dilatation Catheter KANEKA Corporation LIT Class II 2015-09-24
K152407 Infinity Delta, Infinity Delta XL, Infinity Kappa Draeger Medical Sytems, Inc. MHX Class II 2015-09-23
K152379 iHealth View BP7S Wireless Blood Pressure Wrist Monitor Andon Health Co, Ltd. DXN Class II 2015-09-23
K151951 Destino Reach Oscor, Inc. DYB Class II 2015-09-22
K142349 TM eCloud ECG Analysis System Telemed Solutions, Inc. DQK Class II 2015-09-21
K151313 ZelanteDVT Thrombectomy Set Boston Scientific Corporation QEW Class II 2015-09-21
K152404 Hi-Torque Command 18 Guide Wire Abbott Vascular DQX Class II 2015-09-21
K152218 AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System Osprey Medical DXT Class II 2015-09-21
K151678 Chameleon PTA Balloon Catheter Av Medical Technologies, Ltd. LIT Class II 2015-09-21
K152161 Thoratec CentriMag Return (Arterial) Cannula Kit Thoratec Corporation DWF Class II 2015-09-18
K152190 Thoratec CentriMag Drainage (Venous) Cannula Kit Thoratec Corporation DWF Class II 2015-09-18
K152335 Export Advance Aspiration Catheter Medtronic, Inc. DXE Class II 2015-09-18
K151189 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System Devon Medical Products JOW Class II 2015-09-18
K151071 SmartLinx Vitals Plus Patient Monitoring System Capsule Technologie Sas MWI Class II 2015-09-17
K151188 BodyGuardian Remote Monitoring System Preventice DSI Class II 2015-09-17
K150958 LifePearl Microshperes MicroVention, Inc. KRD Class II 2015-09-17
K151245 Rhythm View Workstation (non-streaming, steaming option) Topera, Inc. DQK Class II 2015-09-15
K151554 Occlusion Perfusion Catheter Advanced Catheter Therapies, Inc. QEY Class II 2015-09-15
K143359 CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector Lifewatch Technologies , Ltd. DSI Class II 2015-09-11
K151460 Fully Automatic Electronic Blood Pressure Monitor Andon Health Co, Ltd. DXN Class II 2015-09-08
K150442 Volcano Visions PV .018 Digital IVUS Catheter Volcano Corporation OBJ Class II 2015-09-04
K151040 Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer Biometrix , Ltd. DRS Class II 2015-09-04
K152230 Ebony PTA .014 RX Pheripheral Dilatation Catheter Natec Medical LIT Class II 2015-09-03
K150352 V Series Monitoring System (including V12 and V21 Monitors) Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2015-09-02
K151860 Infinity CentralStation Wide Draeger Medical Systems, Inc. MHX Class II 2015-09-02
K151869 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH, Switzerland DXN Class II 2015-09-02
K150082 Panorama Patient Monitoring Network Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2015-09-02
K151006 EarlySense Central Display Station (CDS) Earlysense, Ltd. MSX Class II 2015-08-31
K151206 Fingertip Pulse Oximeter Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2015-08-28
K151319 Eko Electronic Stethoscope System Eko Devices, Inc. DQD Class II 2015-08-28
K150894 VIA 21 Microcatheter Sequent Medical, Inc. DQY Class II 2015-08-28
K143454 Pruitt F3-S Carotid Shunt LeMaitre Vascular, Inc. MJN Class II 2015-08-27
K152116 5.5 F Worley Advanced LVI Lateral Vein Introducer Merit Medical Systems, Inc. DYB Class II 2015-08-27
K151305 SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) Nonin Medical, Inc. MUD Class II 2015-08-27
K150289 CARDIOLINE HD+ Cardioline S.P.A DRG Class II 2015-08-27
K151349 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation DTQ Class II 2015-08-27

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