meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
2012-03-29

Clearances · page 55 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K120738 FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM Ostial Corporation LIT Class II 2012-03-29
K120630 AZUR DETACHABLE 18 MicroVention, Inc. KRD Class II 2012-03-28
K113798 INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET Draeger Medical Systems, Inc. MHX Class II 2012-03-22
K113220 EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation LOX Class II 2012-03-22
K113657 INTELLIVUE PATIENT MONITOR Philips Medizin Systeme Boblingen GmbH MHX Class II 2012-03-22
K113441 PHYSIOLOGICAL MONITOR, PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2012-03-22
K112573 EZSLEEP SLEEP QUALITY RECORDER Platinum Team Co., Ltd. MWJ Class II 2012-03-22
K112478 VISI MOBILE MONITORING SYSTEM Sotera Wireless, Inc. MWI Class II 2012-03-22
K112887 UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR Upstream Peripheral Technologies DYB Class II 2012-03-21
K113865 PULTOL Sharp Corporation DQA Class II 2012-03-21
K112432 ZOLL X SERIES Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2012-03-21
K112100 M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER Vascular Solutions, Inc. DQY Class II 2012-03-20
K120544 RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN St Jude Medical DRF Class II 2012-03-19
K113515 HORIZON CARDIOLOGY ECG MANAGEMENT Mckesson Israel , Ltd. DQK Class II 2012-03-16
K113239 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) Health & Life Co., Ltd. DXN Class II 2012-03-16
K113811 V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM C.R. Bard Inc., Bard Electrophysiology Division DQK Class II 2012-03-16
K120188 ELECTROCARDIOGRAPH Edan Instruments, Inc. DPS Class II 2012-03-16
K120480 GORE(R) EMBOLIC FILTER W.L. Gore & Associates NTE Class II 2012-03-16
K112998 AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 Zoll Circulation DRM Class II 2012-03-15
K112404 CONCENTRIC BALLOON GUIDE CATHETER Concentric Medical, Inc. DQY Class II 2012-03-15
K120120 AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH Aga Medical Corporation DQY Class II 2012-03-15
K120677 CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) Trireme Medical, Inc. LIT Class II 2012-03-15
K120660 CONQUEST 40 PTA DILATATION CATHETER Bard Peripheral Vascular, Inc. LIT Class II 2012-03-15
K113838 WILDCAT CATHETER Avinger, Inc. PDU Class II 2012-03-12
K113260 MODIFIED CONCENTIRC MICROCATHETER Concentric Medical, Inc. DQO Class II 2012-03-09
K113372 NUVANT, MOBILC CARDIAC TELEMETRY Corventis, Inc. QYX Class II 2012-03-07
K113464 NC TREK OTW CORONARY DILATATION CATHETER Abbott Vascular LOX Class II 2012-03-06
K113455 SOLITAIRE FR REVASCULARIZATION DEVICE Micro Therapeutics Dba Ev3 Neurovascular NRY Class II 2012-03-02
K113584 PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER St Jude Medical DXO Class II 2012-03-02
K111544 GLIDER PTCA BALLOON CATHETER Trireme Medical, Inc. LOX Class II 2012-03-02
K113264 ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) Ld Technology, LLC DXN Class II 2012-03-02
K113238 FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR Health & Life Co., Ltd. DXN Class II 2012-03-01
K113148 E-PASS Synexmed(Shenzhen)Company Limited DTL Class II 2012-02-28
K120381 Q50 PLUS STENT GRAFT BALLOON CATHETER Qxmedical, LLC DQY Class II 2012-02-24
K120343 CONNEX WORKSTATION Welch Allyn, Inc. MWI Class II 2012-02-24
K112691 BLOOD PRESSURE MONITOR Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2012-02-24
K120242 JETSTREAM NAVITUS L SYSTEM Pathway Medical Technologies, Inc. MCW Class II 2012-02-24
K113596 MASIMO SET REUSABLE OXIMETRY SENSORS Masimo Corporation DQA Class II 2012-02-24
K113454 14 WIRE STANDARD, 14 WIRE LS Micro Therapeutics, Inc. DQX Class II 2012-02-24
K112690 BLOOD PRESSURE MONITOR Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2012-02-24
K120301 MEDIGUIDE TECHNOLOGY St. Jude Medical, Mediguide Navigation Systems DQK Class II 2012-02-24
K120229 ENVOY DISTAL ACCESS GUIDING CATHETER Codman & Shurtleff, Inc. DQY Class II 2012-02-24
K113737 SUREFIRE GUIDE SHEATH Surefire Medical, Inc. DQO Class II 2012-02-23
K112886 UPSTREAM SUPPORT CATHETER Upstream Peripheral Technologies DQY Class II 2012-02-23
K113757 ASPIRE MAX ASPIRATION CATHETER Control Medical Technology, LLC QEZ Class II 2012-02-22
K113514 SMARTHEART Shl Telemedicine International , Ltd. DXH Class II 2012-02-22
K111141 BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR Wenzhou Bokang Instruments Co., Ltd. DXN Class II 2012-02-21
K113054 EQUIVITAL Hidalgo Limited MHX Class II 2012-02-17
K120081 NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS Cincinnati Sub-Zero Products, Inc. DWJ Class II 2012-02-17
K110825 PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES Philips Medical Systems MKJ Class III 2012-02-16
K112831 PLEURX PLEURAL CATHETER SYSTEMS Care Fusion DWM Class II 2012-02-16
K120137 VICTORY GUIDEWIRE (32 MODELS) Brivant, Ltd. DQX Class II 2012-02-14
K120132 SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR Philips Medical Systems DXN Class II 2012-02-14
K120144 VITAL SIGNS MONITOR Edan Instruments, Inc. DXN Class II 2012-02-14
K112042 KINGYIELD WRIST BLOOD PRESSURE MONITOR Shenzhen Kingyield Technology Co., Ltd. DXN Class II 2012-02-10
K112407 SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS Smiths Medical MD, Inc. DYB Class II 2012-02-09
K113183 PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 Shanghai 3f Electronics Co, Ltd. MWI Class II 2012-02-09
K120212 AFX INTRODUCER SYSTEM Endologix, Inc. DYB Class II 2012-02-09
K120178 WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical DQY Class II 2012-02-08
K113600 IM BAND Synexmed(Shenzhen)Company Limited DXC Class II 2012-02-08
K112541 Z FLEX-270TM STEERABLE SHEATH Great Batch Medical DRA Class II 2012-02-07
K113214 TLINK DATA MANAGEMENT SYSTEM (DMS) Terumo Cardiovascular Systems Corp. DXJ Class II 2012-02-07
K113196 VASCULAR SONO PAJUNK GmbH Medizintechnologie DYB Class II 2012-02-06
K113716 ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE Asahi Intecc Co., Ltd. DQX Class II 2012-02-06
K113862 ZIO PATCH iRhythm Technologies, Inc. DSH Class II 2012-02-06
K113653 PATIENT MONITOR Edan Instruments, Inc. MHX Class II 2012-02-06
K120129 MANTARAY CATHETER Bridgepoint Medical DQY Class II 2012-02-03
K120006 HERO GRAFT Hemosphere, Inc. DSY Class II 2012-02-02
K113165 MINI-MEDIC Athena Gtx MWI Class II 2012-02-02
K110051 RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT Great Batch Medical DYB Class II 2012-02-02
K112650 CONNEXALL SUITE OF SOFTWARE PRODUCTS Connexall USA, Inc. MSX Class II 2012-02-01
K113623 PATIENT MONITOR Edan Instruments, Inc. MHX Class II 2012-02-01
K120058 TRANSTEK BLOOD PRESSURE MONITOR Zhongshan Transtek Electronics Co., Ltd. DXN Class II 2012-01-31
K113525 ACTIVECARE DVT ACTIVECARE+SFT Medical Compression Systems (Dbn) , Ltd. JOW Class II 2012-01-31
K112804 FINGERTIP PULSE OXIMETER Guangdong Biolight Meditech Co., Ltd. DQA Class II 2012-01-27
K113185 MODEL HBP-1300 Omron Healthcare, Inc. DXN Class II 2012-01-27
K112959 CALG-STR EXERCISE ECG ANALYSIS ALGORITHM Philips Health Care DPS Class II 2012-01-26
K112820 FORE-SIGHT ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. MUD Class II 2012-01-26
K113845 TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE Medtronic, Inc. DTL Class II 2012-01-25
K112858 GENESIS TOUCH SYSTEM Honeywell Hommed, LLC DRG Class II 2012-01-24
K113769 GPSCATH BALLON DILATATION CATHETER Hotspur Technologies LIT Class II 2012-01-20
K112662 MICROFRANCE(R) WORMALD VASCULAR CLAMP Medtronic Xomed, Inc. DXC Class II 2012-01-20
K113132 DISPOSABLE HEMOSTATIC Y-CONNECTORS Coeur, Inc. DTL Class II 2012-01-20
K113083 TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR Truly Instrument Co., Ltd. DXN Class II 2012-01-19
K120010 CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) Shenzhen Med-Link Electronics Tech Co., Ltd. DSA Class II 2012-01-19
K113773 ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL St Jude Medical KRA Class II 2012-01-18
K112825 AVITA ARM TYPE BLOOD PRESSURE MONITOR Avita Corporation DXN Class II 2012-01-18
K111494 HANDHELD PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2012-01-18
K113101 EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL Boston Scientific Corporation DSY Class II 2012-01-17
K112677 THE VENOUS ASSIST SYSTEM Daesung Maref Co., Ltd. JOW Class II 2012-01-13
K113698 SCEPTER XC OCCLUSION BALLOON CATHETER MicroVention, Inc. MJN Class II 2012-01-13
K113085 TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR Truly Instrument Co., Ltd. DXN Class II 2012-01-12
K102439 FUNNEL GUIDE CATHETER MODEL G1020608 Lazarus Effect, Inc. DQY Class II 2012-01-12
K113667 CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING Edwards Lifesciences, LLC DTL Class II 2012-01-12
K113681 GLADIATOR PTA BALLOON DILATION CATHETER Boston Scientific LIT Class II 2012-01-11
K113651 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM Boston Scientific Corporation KRD Class II 2012-01-11
K111730 SONOTT FLOWLAB(R) Em-Tec GmbH DPW Class II 2012-01-06
K112035 VALET MICRO CATHETER Volcano Corporation DQY Class II 2012-01-05
K113638 NMI 2.8 MICROCATHETER Navilyst Medical, Inc. DQO Class II 2012-01-05
K113589 BIGBOSS CATHETER Bridgepoint Medical DQY Class II 2012-01-04

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