meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
49
Latest Decision
2018-01-22

Clearances · page 32 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K171360 CONTEC™ Electrocardiograph Contec Medical Systems Co.,Ltd DPS Class II 2018-01-22
K173891 Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume Vascular Solutions, Inc. KRD Class II 2018-01-19
K172259 PulsioFlex Monitoring System Pulsion Medical Systems SE DXG Class II 2018-01-18
K173820 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation OBJ Class II 2018-01-17
K173795 HI-TORQUE TurnTrac Guide Wire Family Abbott Vascular DQX Class II 2018-01-12
K173560 Microcatheter Surmodics,Inc. DQY Class II 2018-01-12
K172655 Automated ankle brachial pressure index measuring device Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. JOM Class II 2018-01-11
K171517 Digital Electrocardiograph Biocare Bio-Medical Equipment Co., Ltd. DPS Class II 2018-01-11
K171665 Microcatheter and guide-wire system Suzhou Hengrui Disheng Medical Co., Ltd. KRA Class II 2018-01-11
K173768 Tempus Pro Patient Monitor Remote Diagnostic Technologies , Ltd. MHX Class II 2018-01-10
K173170 Epicardia Anywhere Medicomp, Inc. DSI Class II 2018-01-10
K171445 Amplatz Support Wire Guide with Apex Curve Cook Incorporated DQX Class II 2018-01-10
K173563 ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE Tz Medical, Inc. DXC Class II 2018-01-10
K171833 Digital Blood Pressure Monitor-Wrist Style Shenzhen Combei Technology Co., Ltd. DXN Class II 2018-01-10
K171948 Roadrunner Extra Support Wire Guide Cook Incorporated DQX Class II 2018-01-05
K172029 EnsoETM Attune Medical PLA Class II 2018-01-05
K171056 WAVE Clinical Platform Excel Medical Electronics, LLC MWI Class II 2018-01-04
K171410 ePatch Braemar Manufacturing, LLC DSH Class II 2018-01-04
K171819 Attain Assist CS Access Catheter Creganna Medical Also Doing Business AS Ceganna Tactx Medica DQY Class II 2018-01-04
K172507 SOZO ImpediMed Limited DSB Class II 2017-12-22
K172448 Riptide Aspiration System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular NRY Class II 2017-12-21
K172893 SafeSept Needle Free Transseptal Guidewire Pressure Products Medical Device Manufacturing, LLC DRC Class II 2017-12-21
K173287 Elite HV Radial Galt Medical Corp. DYB Class II 2017-12-21
K171275 Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design Cook Incorporated DYB Class II 2017-12-20
K173662 speX Support Catheter Reflow Medical, Inc. DQY Class II 2017-12-20
K173685 Peel-Away Introducer Set Cook Incorporated DYB Class II 2017-12-20
K171866 Sentrant Introducer Sheath with Hydrophilic Coating Medtronic Vascular, Inc. DYB Class II 2017-12-20
K173618 ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Siemens Medical Solutions USA, Inc. OBJ Class II 2017-12-19
K171889 Reusable Blood Pressure Cuff Suzhou Minhua Medical Apparatus Supplies Co., Ltd. DXQ Class II 2017-12-19
K173696 TBL-ABI System Ld Technology, LLC JOM Class II 2017-12-19
K172311 BioFlux Device Biotricity, Inc. DXH Class II 2017-12-15
K163607 ECG Acquisition Systems Vales & Hills Biomedical Tech. , Ltd. DPS Class II 2017-12-15
K172494 PROTEUS PTA Balloon Catheter with Embolic Capture Feature Angioslide, Ltd. LIT Class II 2017-12-15
K170029 FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile International Biophysics Corporation KFM Class II 2017-12-15
K170497 V10 Mediana Co., Ltd. DXN Class II 2017-12-15
K173532 Raider Guidewire Vascular Solutions, Inc. DQX Class II 2017-12-15
K172482 The Nellcor pulse oximetry monitor interface cable Covidien DQA Class II 2017-12-15
K173621 Advocate PTA Catheter Merit Medical Systems, Inc. LIT Class II 2017-12-13
K172932 True Flow Valvuloplasty Perfusion Catheter C.R. Bard, Inc. OZT Class II 2017-12-13
K170279 Disposable High Pressure Syringe Union Medical Shenzhen Co., Ltd. DXT Class II 2017-12-12
K171186 Cerebrotech CMS-5000 Cerebrotech Medical Systems QAF Class II 2017-12-08
K172966 CMS-2000 Central Monitoring System Advanced Instumentations, Inc. MHX Class II 2017-12-08
K171513 Lunderquist Extra Stiff Wire Guide William Cook Europe Aps DQX Class II 2017-12-07
K172468 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm Inneuroco, Inc. DQY Class II 2017-12-06
K172085 PhotoFix Decellularized Bovine Pericardium Cryolife, Inc. PSQ Class II 2017-12-04
K173470 ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical QEW Class II 2017-12-04
K173266 Octane aspiration system Vascular Solutions, Inc. QEZ Class II 2017-12-01
K173399 Endophys Pressure Sensing Sheath Kit- 8F Endophys Holdings, LLC DYB Class II 2017-11-30
K172637 HeRO Graft Merit Medical Systems, Inc. DSY Class II 2017-11-30
K172687 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. MCW Class II 2017-11-27
K172030 Devon 51 Devon Medical Products (Jiangsu), Ltd. JOW Class II 2017-11-27
K170666 The Wrist-Type Fully Automatic Digital Blood Pressure Monitors Joytech Healthcare Co. , Ltd. DXN Class II 2017-11-22
K170915 TXM Hydrophilic Guidewire Texasmedical Technologies, Inc. DQX Class II 2017-11-21
K170914 TXM Support Catheter Texasmedical Technologies, Inc. DQY Class II 2017-11-21
K172995 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Terumo Medical Corporation DYB Class II 2017-11-21
K170545 Automatic Wrist Bluetooth Blood Pressure Monitor Truly Instrument , Ltd. DXN Class II 2017-11-21
K172557 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach William Cook Europe Aps DTK Class II 2017-11-20
K172584 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach William Cook Europe Aps DTK Class II 2017-11-20
K173044 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff Ningbo Albert Novosino Co., Ltd. DXQ Class II 2017-11-20
K172984 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface Medtronic, Inc. DTZ Class II 2017-11-20
K171121 Masimo Root Monitoring System and Accessories Masimo Corporation MWI Class II 2017-11-17
K173068 Performer Introducer Cook Incorporated DYB Class II 2017-11-17
K172660 Duravess bovine pericardial vascular patch Edwards Lifesciences, LLC PSQ Class II 2017-11-17
K170544 Langston dual lumen catheter Vascular Solutions, Inc. DQO Class II 2017-11-17
K173423 MR Wire Guide Wire Straight, MR Wire Guide Wire Angled Nano4imaging GmbH DQX Class II 2017-11-17
K171610 MC3 QuickFlow Dual Lumen Catheter Mc3 Incorporated PZS Class II 2017-11-16
K173284 OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation OBJ Class II 2017-11-16
K163472 Intra.Ox Handheld Tissue Oximeter Vioptix, Inc. MUD Class II 2017-11-16
K171816 Kardia Band System AliveCor, Inc. DXH Class II 2017-11-16
K173289 Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter Cook Incorporated DQO Class II 2017-11-15
K171901 uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2017-11-15
K170931 CXI TriForce Peripheral Crossing Set Cook Incorporated KRA Class II 2017-11-13
K172226 MX40 Release B.07 Philips Medical Systems MHX Class II 2017-11-09
K171392 ulrichINJECT CT motion Ulrich GmbH & Co. KG IZQ Class II 2017-11-09
K170664 Odyssey Micro Catheter Heraeus Medical Components, LLC DQY Class II 2017-11-09
K172453 WATCHDOG Hemostasis Valve Kit Boston Scientific Corporation DQX Class II 2017-11-09
K172458 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit Smiths Medical Asd, Inc. DRS Class II 2017-11-09
K172790 ER-REBOA Catheter Prytime Medical Devices, Inc. MJN Class II 2017-11-08
K163694 Rooti Rx ECG Event Recorder, Rooti Link APP Software Rooti Labs , Ltd. DRG Class II 2017-11-07
K170965 Fingertip Pulse Oximeter Shenzhen Jumper Medical Equipment Co., Ltd. DQA Class II 2017-11-03
K172591 Fixed Patient Leads ECG Cable (Model 3153) Boston Scientific Corporation DSA Class II 2017-11-03
K172277 Phlebo Press DVT Model Mego Afek AC , Ltd. JOW Class II 2017-11-03
K171788 Reprocessed Halo XP Diagnostic Electrophysiology Catheter Innovative Health, LLC NLH Class II 2017-11-03
K173232 myMerlin(TM) Mobile Application Model APP1001 St Jude Medical MXC Class II 2017-11-02
K163453 VitalPatch® VitalConnect Platform Vitalconnect, Inc. DRG Class II 2017-11-02
K171580 Monitor B125, Monitor B105 Ge Medical Systems (China) Co., Ltd. MHX Class II 2017-11-01
K172296 Stethee Pro M3Dicine Pty , Ltd. DQD Class II 2017-10-30
K172236 Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled Avinger, Inc. MCW Class II 2017-10-30
K170466 Automatic Blood Pressure Monitor Model LD-518 & LD-537 Honsun (Nantong) Co., Ltd. DXN Class II 2017-10-27
K171979 Tubing Pack Medtronic, Inc. DWF Class II 2017-10-27
K170454 Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U Honsun (Nantong) Co., Ltd. DXN Class II 2017-10-25
K172626 Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir Medtronic, Inc. DTZ Class II 2017-10-25
K172200 3880 MRI Patient Monitoring System Iradimed Corporation MWI Class II 2017-10-25
K171946 Gel-Bead Vascular Solutions, Inc. KRD Class II 2017-10-25
K171751 SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module Capsule Technologie Sas MWI Class II 2017-10-24
K172000 ClearLumen II Peripheral Thrombectomy System Walk Vascular, LLC QEZ Class II 2017-10-24
K171996 TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC DXO Class II 2017-10-23
K171277 Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC DRF Class II 2017-10-23
K173063 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System Acist Medical Systems, Inc. OBJ Class II 2017-10-23
K173052 Heraeus TMW Guidewire Heraeus Medical Components, LLC DQX Class II 2017-10-20

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