meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
2014-08-18

Clearances · page 45 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133703 PHYSIOGLOVE ET SYSTEM Commwell R&D , Ltd. DXH Class II 2014-08-18
K141769 OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER Lightlab Imaging, Inc. DQO Class II 2014-08-18
K141951 DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE Medtronic, Inc. DWF Class II 2014-08-15
K140933 ALIVECOR HEART MONITOR AliveCor, Inc. DXH Class II 2014-08-15
K141090 NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER Medtronic, Inc. LOX Class II 2014-08-15
K133973 TEMPUS PRO WITH ENHANCED FEATURES Remote Diagnostic Technologies , Ltd. QYW Class II 2014-08-14
K141128 FINGERTIP PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2014-08-13
K134014 TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) Remote Diagnostic Technologies , Ltd. MWI Class II 2014-08-12
K142116 LLD EZ Spectranetics, Inc. DRB Class II 2014-08-12
K141782 HI-TORQUE VERSATURN GUIDE WIRE Abbott Vascular DQX Class II 2014-08-07
K141209 EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES Celonova Biosciences, Inc. KRD Class II 2014-08-07
K141236 NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation LOX Class II 2014-08-07
K141614 MAGELLAN ROBOTIC SYSTEM Hansen Medical DXX Class II 2014-08-07
K140999 TANDEMHEART VENO-VENOUS CANNULA Cardiacassist, Inc. DWF Class II 2014-08-06
K133222 SAAD PATIENT MONITOR (SPM) Hanin Medical Services Co., Ltd. MHX Class II 2014-08-06
K141813 RHYTHMSTAR SYSTEM RhythMedix, LLC DXH Class II 2014-08-05
K141822 SENSEI X ROBOTIC CATHETER SYSTEM Hanson Medical, Inc. DXX Class II 2014-08-05
K141496 MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER Reflectance Medical, Inc. MUD Class II 2014-08-04
K132662 PASSPORT SERIES PATIENT MONITORS Shenzhen Mindray Biomedical Electronics Co., Ltd. MHX Class II 2014-08-01
K133484 ZOLL X SERIES Zoll Medical Corp MKJ Class III 2014-08-01
K132892 TEBCO-W Bomed, Inc. DXG Class II 2014-08-01
K133725 TRAXCESS 14 GUIDEWIRE MicroVention, Inc. MOF Class II 2014-07-31
K132293 SYVEK RADIAL BAND Marine Polymer Technologies DXC Class II 2014-07-31
K132516 OXIPROBE E (OXIPROBE) Bio Medical Technologies Co., Ltd. DQA Class II 2014-07-30
K141167 VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) Vitalconnect, Inc. DRG Class II 2014-07-29
K140469 MR SYRINGE DUAL PACK Coeur, Inc. DXT Class II 2014-07-28
K140635 COCOON CONVECTIVE WARMING SYSTEM Care Essentials Pty, Ltd. DWJ Class II 2014-07-25
K133658 CDI BLOOD PARAMETER MONITORING SYSTEM 500 Terumo Cardiovascular Systems Corp. DRY Class II 2014-07-25
K134029 BELTER BLOOD PRESSURE METER Shenzhen Belter Health Measurement and Analysis TE DXN Class II 2014-07-25
K140096 HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE Hmicro, Inc. DRX Class II 2014-07-24
K140775 TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM Spectranetics Corporation MCW Class II 2014-07-23
K140273 EQUALIZER OCCLUSION BALLOON CATHETER Boston Scientific Corp MJN Class II 2014-07-22
K141678 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Abbott Vascular NTE Class II 2014-07-22
K134031 THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER Boston Scientific Corporation LOX Class II 2014-07-21
K141118 NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER Ev3, Inc. LIT Class II 2014-07-18
K140682 FINGERTIP PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2014-07-17
K141112 STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER Boston Scientific LIT Class II 2014-07-16
K140789 CORMATRIX ECM FOR VASCULAR REPAIR Cormatrix Cardiovascular, Inc. DXZ Class II 2014-07-15
K140813 REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES Covidien JOW Class II 2014-07-15
K141609 PULSTAR LOGIX PUMP Albahealth, LLC JOW Class II 2014-07-15
K141582 CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION Welch Allyn DPS Class II 2014-07-11
K140513 MERIT SAFETY INTRODUCER NEEDLE Merit Medical Systems, Inc. DYB Class II 2014-07-09
K140917 INTRODUCER, MODEL ADELANTE MAGNUM Oscor, Inc. DYB Class II 2014-07-09
K141618 ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS Arrow International, Inc (Subsidiary of Teleflex I OBJ Class II 2014-07-08
K141432 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH Maquet Cardiopulmonary, AG DTN Class II 2014-07-07
K140785 PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2014-07-07
K140641 VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA Boston Scientific Corporation DYB Class II 2014-07-03
K133114 MICROPUNCTURE INTRODUCER SET Cook Incorporated DYB Class II 2014-07-03
K140241 EDWARDS TRANSFEMORAL BALLOON CATHETER Edwards Lifesciences, LLC OZT Class II 2014-07-03
K140121 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2014-07-02
K140572 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Microlife Intellectual Property GmbH, Switzerland DXN Class II 2014-07-02
K141392 SPHYGMOMANOMETER Suzhou JJ Meter Co., Ltd. DXQ Class II 2014-07-02
K133861 FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM Ostial Corporation LIT Class II 2014-07-02
K140129 PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER Icu Medical, Inc. DQE Class II 2014-07-02
K140351 ARROW GPSCATH BALLOON DILATATION CATHETER Hotspur Technologies,Inc Subsidiary of Teleflex ME LIT Class II 2014-07-02
K141234 ODISSEY TISSUE OXIMETER Vioptix, Inc. MUD Class II 2014-07-01
K132036 HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. MSX Class II 2014-07-01
K141148 EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET Cook Vascular, Inc. DRE Class II 2014-07-01
K133916 CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 Biosense Webster, Inc. DQK Class II 2014-07-01
K133189 DUAL SHOT ALPHA 7 Nemoto Kyorindo Co., Ltd. DXT Class II 2014-06-30
K141179 A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR A & D Co., Ltd. DXN Class II 2014-06-27
K141578 DEVON CIRONA 6200 DVT Devon Medical JOW Class II 2014-06-27
K133843 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER Cordis Corporation LIT Class II 2014-06-27
K133961 SURESIGNS VS3, SURESIGNS VS4 Philips Medical Systems DSJ Class II 2014-06-26
K140188 MASIMO ROOT MONITORING SYSTEM Masimo Corporation MWI Class II 2014-06-25
K131416 NOVOPRESS Milka, LLC JOW Class II 2014-06-23
K140067 QARDIOARM Qardio, Inc. DXN Class II 2014-06-18
K140583 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES Grandway Technology (Shenzhen) Limited DXN Class II 2014-06-18
K141313 REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM Reverse Medical Corporation KRD Class II 2014-06-18
K140312 EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM Edwards Lifesciences, LLC DXN Class II 2014-06-13
K140430 740 SELECT Cas Medical Systems, Inc. MWI Class II 2014-06-13
K141360 TRIPLEPLAY PRO Wildcat Medical, Inc. JOW Class II 2014-06-12
K140695 COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE Medtronic, Inc. DQX Class II 2014-06-12
K141233 AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE Medtronic, Inc. DTN Class II 2014-06-12
K140425 CONTRAST MODULATION SYSTEM Osprey Medical, Inc. DXT Class II 2014-06-11
K131858 DIGITAL ELECTROCARDIOGRAPH Guangdong Biolight Meditech Co., Ltd. DPS Class II 2014-06-11
K140642 PCD 737A Mego Afek AC , Ltd. JOW Class II 2014-06-10
K141050 ENSITE VELOCITY SYSTEM St Jude Medical DQK Class II 2014-06-06
K140972 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING Medtronic, Inc. LDF Class II 2014-06-06
K131762 HANDHELD MONITOR Guangdong Biolight Meditech Co., Ltd. MWI Class II 2014-06-06
K140871 AXERA 2 ACCESS SYSTEM Arstasis, Inc. DYB Class II 2014-06-06
K141185 V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM Boston Scientific Corp DQK Class II 2014-06-06
K132960 BIOMONITOR Biotronik, Inc. MXD Class II 2014-06-06
K141060 CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT On-X Life Technologies, Inc. PAW Class II 2014-06-06
K133872 ARIA WIFI SMART SCALE Fitbit, Inc. MNW Class II 2014-06-02
K140774 TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR Terumo Cardiovascular Systems Corporation DTZ Class II 2014-06-02
K133633 CHOCOLATE PTCA BOLLOON CATHETER Trireme Medical, Inc. LOX Class II 2014-06-02
K132173 FAMILY HEALTHWARE Sanitas, Inc. DRG Class II 2014-05-30
K141124 SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT Vascular Flow Technologies, Ltd. DSY Class II 2014-05-30
K140594 BODY FAT ANALYZER AND SCALE Conmo Electronic Company Limited MNW Class II 2014-05-30
K132730 BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE Medtronic, Inc. DPT Class II 2014-05-30
K133481 SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) St. Jude Medical, Inc. MXC Class II 2014-05-28
K141131 TIGHTRAIL MINI Spectranetics, Inc. DRE Class II 2014-05-23
K140548 CORCAM HEART MONITOR Corcam Technologia, SA DSI Class II 2014-05-23
K131588 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR Edwards Lifesciences, LLC DXG Class II 2014-05-22
K133269 ZOLL X SERIES Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2014-05-22
K131892 EV1000 CLINICAL PLATFORM Edwards Lifesciences, LLC DXG Class II 2014-05-22
K140412 ANS1 SOFTWARE Ld Technology, LLC DXN Class II 2014-05-22
K140192 CARPENTIER BI-CAVAL FEMORAL CANNULA Medtronic, Inc. DWF Class II 2014-05-22
K140151 EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT Btg International, Inc. QEY Class II 2014-05-21

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