meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
39
Latest Decision
2012-09-05

Clearances · page 53 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K121415 MOLLRING MULTITASC LeMaitre Vascular, Inc. DWX Class II 2012-09-05
K122379 FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM Ostial Corporation LIT Class II 2012-09-05
K120052 CVINSIGHT Intelomed, Inc. DQA Class II 2012-09-04
K121196 EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corp LOX Class II 2012-08-31
K113705 PINTLER PATIENT WARMING SYSTEM Pintler Medical DWJ Class II 2012-08-31
K121859 TYSHAK NUCLEUS NuMED, Inc. DQY Class II 2012-08-31
K122394 RUBICON 18 SUPPORT CATHETER Boston Scientific Corp DQY Class II 2012-08-30
K122281 PADNET 2.0 Biomedix, Inc. JOM Class II 2012-08-29
K121932 HEM-7200-Z (BP742) Omron Healthcare, Inc. DXN Class II 2012-08-29
K122439 INTELLIVUE PATIENT MONITOR Philips Medizin Systeme Boeblingen GmbH MHX Class II 2012-08-29
K122275 ARTISAN EXTEND CONTROL CATHETER Hansen Medical DRA Class II 2012-08-29
K122316 AZUR DETACHABLE 35 MicroVention, Inc. KRD Class II 2012-08-29
K122084 INTRODUCER SET, MODEL ADELANTE-S SERIES Oscor, Inc. DYB Class II 2012-08-29
K122254 INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR Sorin Group Italia S.R.L. DTZ Class II 2012-08-24
K121611 AMPLATZER TORQVUE FX Aga Medical Corporation DQY Class II 2012-08-23
K111603 LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM Ep Dynamics, Inc. DYB Class II 2012-08-23
K121536 INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR Sorin Group Italia S.R.L. DTZ Class II 2012-08-22
K121185 EDWARDS PERCUTANEOUS SHEATH INTRODUCER Edwards Lifesciences, LLC DYB Class II 2012-08-22
K121720 WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM Welkins, LLC DWJ Class II 2012-08-20
K122179 VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) Compression Therapy Concepts JOW Class II 2012-08-20
K121025 YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION Ya Horng Electronic Co., Ltd. DXN Class II 2012-08-17
K122190 PRELUDE 7F SHORT SHEATH INTRODUCER Merit Medical Systems, Inc. DYB Class II 2012-08-17
K121718 A-V FOOT PUMP Dalian Labtek Science & Development Co., Ltd. JOW Class II 2012-08-17
K122138 ATRIUM FLIXENE IFG VASCULAR GRAFT Atrium Medical Corp. DSY Class II 2012-08-17
K120008 MEDLINE HIGH PRESSURE INJECTION TUBING Medline Industries, Inc. DQO Class II 2012-08-17
K121173 CHORD-X EPTFE SUTURE On-Xlifetechnologies PAW Class II 2012-08-16
K121352 ARMADA 14XXT PTA CATHETER Abbott Vascular DQY Class II 2012-08-15
K122036 VISI MOBILE MONITORING SYSTEM Sotera Wireless, Inc. MWI Class II 2012-08-15
K122070 CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G Trireme Medical, Inc. LIT Class II 2012-08-15
K120320 CONNECTED CARE CLINICAL APPLICATION Watermark Medical, Inc. DXN Class II 2012-08-14
K121776 AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE Codman & Shurtleff, Inc. DQX Class II 2012-08-14
K113045 BIOHARNESS Zephyr Technology Corporation MHX Class II 2012-08-14
K122285 TABLET COMMANDER Cardiocom, LLC DRG Class II 2012-08-14
K120158 CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS Thomas Medical Products, Inc. DYB Class II 2012-08-14
K121667 NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) Boston Scientific Corp LOX Class II 2012-08-13
K121785 SCEPTER C OCCLUSION BALLOON CATHETER MicroVention, Inc. MJN Class II 2012-08-10
K121197 BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT Preventice, Inc. DSI Class II 2012-08-10
K120554 ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Sejoy Electronics & Instruments Co., Ltd. DXN Class II 2012-08-10
K121429 AIMAGO EASYLDI MICROCIRCULATION CAMERA Aimago SA DPT Class II 2012-08-10
K120781 CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH Fuji Systems Corp. DQY Class II 2012-08-09
K121839 UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. DQY Class II 2012-08-08
K121168 APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH Aptus Endosystems, Inc. OTD Class II 2012-08-08
K113507 KENT CAMERA Kent Imaging, Inc. MUD Class II 2012-08-08
K120585 CONVEY GUIDING CATHETER Pendracare International, B.V. DQY Class II 2012-08-08
K120536 HEART SYNC PEDIATRIC PHYSIO AED PAD Heart Sync, Inc. MKJ Class III 2012-08-06
K121158 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. NLH Class II 2012-08-06
K120961 TREVO RETRIEVER Concentric Medical, Inc. NRY Class II 2012-08-03
K122121 PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE Pulsion Medical Systems SE DXG Class II 2012-08-02
K120430 MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P Microlife Intellectual Property GmbH DXN Class II 2012-08-02
K120917 HEADWAY DUO MICROCATHETER MicroVention, Inc. DQO Class II 2012-08-02
K112620 DISITAL BLOOD PRESSURE MONITOR Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2012-08-02
K122073 ELI 280 ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2012-08-02
K113289 ORION MICRO CATHETER Micro Therapeutics, Inc. KRA Class II 2012-08-01
K113849 HQS INTRODUCER Alseal DYB Class II 2012-07-31
K121301 XPRESSWAY RX CATHETER (6F LD-VERISON) Kaneka Pharma America, LLC QEZ Class II 2012-07-30
K121734 PLATO MICROCATH 27 MICROCATHETER Scientia Vascular, LLC DQO Class II 2012-07-30
K121748 THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL Access Scientific, Inc. DYB Class II 2012-07-27
K121617 SENSICARDIAC Diacoustic Medical (Pty) DQD Class II 2012-07-27
K121013 CONNEX VITAL SIGNS MONITOR 6000 SERIES Welch Allyn, Inc. MWI Class II 2012-07-26
K113869 ORIGEN REINFORCED DUAL LUMEN CATHETER Origen Biomedical, Inc. DWF Class II 2012-07-26
K122095 ICP TRIAGEMANAGER Emergo Europe Consulting BV DRG Class II 2012-07-26
K113656 CAREGUIDE OXIMETER Reflectance Medical, Inc. MUD Class II 2012-07-26
K120896 WI-FI BODY SCALE Andon Health Co, Ltd. MNW Class II 2012-07-26
K121909 INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR Sorin Group Italia S.R.L. DTZ Class II 2012-07-26
K120988 DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT Medtronic, Inc. DWF Class II 2012-07-25
K121912 E1 EAR SENSORS Masimo Corporation DQA Class II 2012-07-24
K121376 COMPRESSION CARE FLIGHT Medical Minds, LLC JOW Class II 2012-07-24
K121229 INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY Sorin Group Italia S.R.L. DTZ Class II 2012-07-23
K120849 HYBRID ARCTICGEL PAD Medivance, Inc. DWJ Class II 2012-07-20
K113162 SLIDEWIRETM(TRADEMARK PENDING) Acme-Monaco Corp. DQX Class II 2012-07-20
K113498 DISPOSABLE TORQUE DEVICE Coeur, Inc. DQX Class II 2012-07-20
K120865 RSCRIBE ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2012-07-19
K112622 HANDHELD ECG MONITOR Beijing Choice Electronic Technololgy Co., Ltd. DPS Class II 2012-07-19
K120834 CORPATH 200 SYSTEM Corindus, Inc. DXX Class II 2012-07-19
K120598 PROCARE MONITOR B40 Ge Medical Systems China Co., Ltd. MHX Class II 2012-07-19
K120366 INTELLIVUE PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2012-07-18
K121355 WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Sejoy Electronics & Instruments Co., Ltd. DXN Class II 2012-07-18
K120325 CONNECTED CARE MOBILE APPLICATION Watermark Medical DRG Class II 2012-07-18
K121319 ZIO PATCH iRhythm Technologies, Inc. DSH Class II 2012-07-18
K121638 ST80I STRESS TEST SYSTEM Philips Health Care DQK Class II 2012-07-18
K121954 NMI MICROCATHETER Navilyst Medical, Inc. DQO Class II 2012-07-17
K120253 ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) Elcam Medical Acal DRG Class II 2012-07-16
K113306 CARDIO 7 Bionet Co., Ltd. DPS Class II 2012-07-16
K113446 VIGNET TELEHEALTH MANAGER Vignet, Inc. DRG Class II 2012-07-16
K113335 HEARTRAIL III GUIDING CATHETER Terumo Corporation DQO Class II 2012-07-16
K120402 CRUX VENA CAVA FILTER SYSTEM Crux Biomedical DTK Class II 2012-07-13
K121745 MANTARAY GUIDEWIRES Bridgepoint Medical DQX Class II 2012-07-13
K113819 MONGOOSE ANGIOGRAPHIC CATHETER Pediacath, Inc. DQO Class II 2012-07-11
K121856 ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION C.R. Bard, Inc. LIT Class II 2012-07-11
K120773 NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM Covidien, LLC DQA Class II 2012-07-10
K112674 NAVIS TORQUER Navis Medical,Inc DQX Class II 2012-07-06
K121871 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING Airstrip Technologies, LP MWI Class II 2012-07-03
K121629 COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR William Cook Europe Aps DTK Class II 2012-07-03
K120941 CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM Constant Care, LLC DRG Class II 2012-07-03
K120884 PERICAM PSI Perimed AB DPT Class II 2012-07-03
K120634 U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM Taidoc Technology Corporation DXN Class II 2012-07-03
K121669 WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) Cincinnati Sub-Zero Products, Inc. DWJ Class II 2012-07-03
K113775 FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM Ostial Corporation LOX Class II 2012-06-29
K120459 STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO Oscor, Inc. DYB Class II 2012-06-29
K120855 INTELLISPACE ECG Philips Health Care DQK Class II 2012-06-29

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