meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
2010-07-23

Clearances · page 62 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K101866 CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH Cryolife, Inc. DXZ Class II 2010-07-23
K100909 REPROCESSED COMPRESSION SLEEVES Ascent Healthcare Solutions JOW Class II 2010-07-23
K101776 SCOUTPRO ACS Biotronik, Inc. DQY Class II 2010-07-23
K101576 CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES Team Innovations, Inc. DRX Class II 2010-07-22
K093981 YRNSORTIP OXIMANOMETER Cnoga Medical , Ltd. DXN Class II 2010-07-22
K101972 SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS Solaris Medical Technology, Inc. DXQ Class II 2010-07-22
K102008 GLIDESHEATH Terumo Medical Corp. DYB Class II 2010-07-21
K101282 SCOUTPRO HEMOSTATIC VALVE Biotronik, Inc. DQY Class II 2010-07-21
K100531 VISCOPE, MODEL 100P,100S Hd Medical Services (India) Pvt.Ltd DQD Class II 2010-07-21
K101674 WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 Athena Gtx MWI Class II 2010-07-21
K101625 COHEN CROSSOVER CATHETER Vascular Solutions, Inc. DQO Class II 2010-07-19
K101092 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 Medivance, Inc. DWJ Class II 2010-07-16
K101117 LEV-OR DILATION CATHETER OTW Baylis Medical Co., Inc. DQY Class II 2010-07-16
K101087 REPROCESSED RESTEP COMPRESSION SLEEVES Ascent Heatlhcare Solutions JOW Class II 2010-07-16
K093903 ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC Genesee Biomedical, Inc. KRH Class II 2010-07-15
K101328 ENSITE VELOCITY SYSTEM St Jude Medical DQK Class II 2010-07-14
K101735 ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY Angioscore, Inc. PNO Class II 2010-07-14
K101047 PTA-DUO PTA BALLOON CATHETER Hotspur Technologies LIT Class II 2010-07-13
K101703 MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 Card Guard Scientific Survival , Ltd. DSI Class II 2010-07-13
K100826 PENUMBRA CATHERER 025 Penumbra, Inc. DQY Class II 2010-07-13
K101570 HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS Micro Therapeutics Dba Ev3 Neurovascular MJN Class II 2010-07-13
K100842 PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM Hotspur Technologies DXE Class II 2010-07-12
K100840 EMBO PLUS EMBOLECTOMY CATHETER Hotspur Technologies DXE Class II 2010-07-12
K100658 U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM Taidoc Technology Corporation DXN Class II 2010-07-09
K100740 MD2000B VITAL SIGN MONITOR, MODEL MD2000B Beijing Choice Electronic Technololgy Co., Ltd. MWI Class II 2010-07-09
K092853 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM Galix Biomedical Instrumentation, Inc. MLO Class II 2010-07-09
K101651 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE Cordis Corp. NTE Class II 2010-07-09
K101680 WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES Welch Allyn, Inc. DXN Class II 2010-07-09
K101022 PULMOTRACK 5050 WHOLTER, MODEL 5050 Karmelsonix DSH Class II 2010-07-09
K100428 MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER Masimo Corporation DQA Class II 2010-07-09
K101648 HI-TORQUE WINN GUIDE WIRE FAMILY Abbott Vascular, Inc. DQX Class II 2010-07-08
K093801 IMPELLA CONTROLLER Abiomed, Inc. KFM Class II 2010-07-08
K100984 XYLOS VESSEL GUARD Xylos Corporation OMR Class II 2010-07-07
K101403 ELI 250 ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2010-07-02
K101487 CHEETAH NICOM SYSTEM Cheetah Medical, Inc. DXG Class II 2010-07-02
K101474 MD VISION SYSTEM Perkins Healthcare Technologies DXJ Class II 2010-07-02
K101705 MISTRAL-AIR WARMING SYSTEM The Surgical Company International B.V. DWJ Class II 2010-07-02
K100620 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 Harvard Medical Devices , Ltd. DXN Class II 2010-07-02
K101667 ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) St Jude Medical DQK Class II 2010-07-02
K101512 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). Microlife Intellectual Property GmbH DXN Class II 2010-07-01
K093877 RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 Edwards Lifesciences, LLC DYB Class II 2010-07-01
K101685 IP-SET Integral Process Sas DRX Class II 2010-07-01
K101669 THERMODILUTION CATHETER Biosensors Intl. Pte. , Ltd. DQO Class II 2010-07-01
K093993 LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 Infraredx, Inc. OGZ Class II 2010-06-30
K101178 MODIFICATION TO INTEL HEALTH GUIDE PHS6000 Intel Corp. DRG Class II 2010-06-29
K100940 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 Andon Health Co, Ltd. DXN Class II 2010-06-29
K101639 CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR Card Guard Scientific Survival , Ltd. DSI Class II 2010-06-25
K101431 ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS C.R. Bard, Inc. DTK Class II 2010-06-25
K100403 MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 Masimo Corporation DQA Class II 2010-06-23
K101116 HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH Abbott Vascular-Cardiac Therapies DQX Class II 2010-06-23
K101345 WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, Biosense Webster, Inc. DRF Class II 2010-06-22
K100631 AFFIITY CP CENTRIFUGAL BLOOD PUMP Medtronic, Inc. KFM Class II 2010-06-22
K101138 SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 Biosense Webster, Inc. OBJ Class II 2010-06-22
K101115 ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 Mortara Instrument, Inc. DPS Class II 2010-06-18
K101449 INTELLIVUE PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2010-06-18
K093376 LASSO NAV CATHETER Biosense Webster, Inc. DRF Class II 2010-06-18
K091786 PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) Pulsion Medical Systems AG DXG Class II 2010-06-18
K093566 CARTO XP EP NAVIGATION SYSTEM, VERSION 10 Biosense Webster, Inc. DQK Class II 2010-06-18
K101399 COAXIAL INTRODUCER SET Martech Medical Products DYB Class II 2010-06-17
K101259 V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 Taidoc Technology Corporation MWI Class II 2010-06-17
K100425 HASKAL TORQUE DEVICE Elcam Medical Acal DQX Class II 2010-06-17
K101523 CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE Devon Medical, Inc. JOW Class II 2010-06-17
K100815 OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 Oxypulse DQA Class II 2010-06-16
K101406 ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 Medrad Interventional/Possis QEZ Class II 2010-06-16
K101334 JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON Pathway Medical Technologies, Inc. MCW Class II 2010-06-11
K101419 ENSITE VELOCITY SYSTEM, MODEL EE3000 St Jude Medical DQK Class II 2010-06-11
K100129 AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X Ambu A/S DRX Class II 2010-06-11
K101127 PATIENT MONITOR, MODEL PM50 Contec Medical System Co., Ltd. MWI Class II 2010-06-11
K101242 GENESIS DM MODEL: 6053000A1 Honeywell Hommed, LLC DRG Class II 2010-06-11
K093931 BLOOD PRESSURE METER, MODEL CH-4532 Citizen Systems Japan Co., Ltd. DXN Class II 2010-06-10
K101445 VITAL SIGNS MONITOR-VSM 6000 SERIES Welch Allyn, Inc. MWI Class II 2010-06-08
K100217 LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 Mediana Co., Ltd. MHX Class II 2010-06-08
K101002 A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 Healthstats International Pte. , Ltd. DXN Class II 2010-06-08
K093853 SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES Nonin Medical, Inc. DQA Class II 2010-06-04
K094056 HOTDOG MULTI FUNCTION CONTROLLER Augustine Biomedical & Design, LLC DWJ Class II 2010-06-03
K093102 AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2010-06-03
K093211 CARECENTER MD Cardiac Science Corporation DPS Class II 2010-06-03
K101239 VIEWFLEX PLUS ICE CATHETER St Jude Medical DQO Class II 2010-06-02
K101221 JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 Pathway Medical Technologies, Inc. MCW Class II 2010-06-02
K100905 HYDROFIX SURGICAL SHEET Mimedx Group, Inc. OMR Class II 2010-06-02
K100254 REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER Ascent Healthcare Solutions NLH Class II 2010-05-28
K100427 FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY Taidoc Technology Corporation DRG Class II 2010-05-28
K101275 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). Microlife Intellectual Property GmbH DXN Class II 2010-05-28
K100617 MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D Masimo Corporation DQA Class II 2010-05-28
K100913 IQVITALS AND IQVITALS SYSTEM Brentwood Medical Technology Corp. DXN Class II 2010-05-26
K100553 BLOOD PRESSURE METER MODEL CH-101 Citizen Systems Japan Co., Ltd. DXN Class II 2010-05-25
K101011 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Abbott Vascular, Inc. DQX Class II 2010-05-24
K100524 POLYTEL(R) APT MODEL: PWA-08-01 Polymap Wireless, LLC DRG Class II 2010-05-24
K091734 SONIC SHOT GX Nemoto Kyorindo Co., Ltd. IZQ Class II 2010-05-21
K101113 GUARDIAN II NC HEMOSTASIS VALVE Zerusa Limited DTL Class II 2010-05-21
K100769 PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 Penumbra, Inc. NRY Class II 2010-05-21
K100677 LYMPHA PRESS 201MAX, MODEL 201MAX Mego Afek AC , Ltd. JOW Class II 2010-05-20
K093895 ALLY PLATFORM SYSTEM Continuity Health Solutions DRG Class II 2010-05-20
K100462 JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 Pathway Medical Technologies, Inc. MCW Class II 2010-05-19
K093992 TERUMO LAUER LOCK ADAPTER Terumo Cardiovascular Systems Corporation DTL Class II 2010-05-19
K100203 HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2010-05-17
K094046 LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS Masimo Corporation DQA Class II 2010-05-14
K100521 COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS Mego Afek AC , Ltd. JOW Class II 2010-05-14
K101062 GLIDER PTA BALLOON CATHETER Trireme Medical, Inc. LIT Class II 2010-05-12
K092219 NAVIGATOR CLINICAL GUIDENCE SYSTEM Applied Physiology Pty , Ltd. DXG Class II 2010-05-12

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