meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
2001-05-23

Clearances · page 99 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K011177 BCI ADVISOR VITAL SIGNS MONITOR (9200) Bci, Inc. DPS Class II 2001-05-23
K010809 BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000 Rf Industries, Ltd. DSA Class II 2001-05-23
K011324 CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM Cambridge Heart, Inc. DQK Class II 2001-05-23
K003918 OSCOR PERMANENT PACING LEAD RZ MODEL SERIES Oscor, Inc. DTB Class III 2001-05-22
K010787 PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS Oscor, Inc. DTD Class II 2001-05-22
K003410 CONCENTRIC RETRIEVER, MODEL 90030 Concentric Medical, Inc. DQY Class II 2001-05-22
K003105 BIOSPHERE MEDICAL INFUSION CATHETER Biosphere Medical DQO Class II 2001-05-22
K010517 ADVANTA SST GRAFT (<6MM) Atrium Medical Corp. DSY Class II 2001-05-18
K003828 VASO PRESS DVT FOOT GARMENT #VP 520 Britt Corp., Inc. JOW Class II 2001-05-18
K010485 VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER Bbraun DTK Class II 2001-05-18
K010162 EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 Micro Therapeutics, Inc. MJN Class II 2001-05-18
K010516 ADVANTA SST GRAFT (>_6MM) Atrium Medical Corp. DSY Class II 2001-05-18
K003084 CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 Concentric Medical, Inc. DQX Class II 2001-05-16
K003880 CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) Concentric Medical, Inc. DQY Class II 2001-05-16
K010587 ACTIVEECG Active Corp. DRT Class II 2001-05-16
K003732 BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES Braun GmbH DXN Class II 2001-05-16
K011217 CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT Abbott Laboratories DQO Class II 2001-05-16
K003707 CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A Cardionet MWJ Class II 2001-05-16
K003086 CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 Concentric Medical, Inc. DQO Class II 2001-05-16
K001694 GUIDANT RETRIEVER DEVICE Guidant Cardiac and Vascular Surgery DQY Class II 2001-05-15
K004012 IMPRA CARBOFLO EPTFE VASCULAR GRAFTS Impra, Inc. DYF Class II 2001-05-14
K003122 SMARTFLOW, MODEL SFIP 2000 Florence Medical , Ltd. DSK Class II 2001-05-14
K010436 TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 Remote Diagnostic Technologies , Ltd. DXH Class II 2001-05-14
K003020 CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER Cd Leycom BV DQO Class II 2001-05-11
K011084 MANDREL GUIDEWIRE ASSEMBLY Lake Region Mfg., Inc. DQX Class II 2001-05-10
K010794 BRIDGE III RECEIVER Meridian Medical Technologies , Ltd. DXH Class II 2001-05-10
K001120 ENVOY PATIENT MONITOR Mennen Medical , Ltd. DSI Class II 2001-05-08
K011098 REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR Medtronic Vascular MXC Class II 2001-05-04
K002256 ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP Arrow Intl., Inc. DSP Class II 2001-05-03
K002186 VASCULAR ASSIST Huntleigh Healthcare, Inc. DPW Class II 2001-05-02
K003320 PTA-OS SIZING BALLOON, MODEL 360 NuMED, Inc. MJN Class II 2001-05-02
K011088 SIII ALARM AMPLIFIER Stockert Instrumente GmbH DTQ Class II 2001-05-02
K002817 SYNETEC Ela Medical, Inc. DQK Class II 2001-05-02
K003819 HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A Agilent Technologies, Inc. MKJ Class III 2001-05-02
K002742 SPHYGMOCOR MX MODEL SCOR-MX Pwv Medical Pty, Lt. DSK Class II 2001-05-01
K011093 AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 Agilent Technologies, Inc. MHX Class II 2001-05-01
K001915 GRAFT MARKER RING T. Korossurgical Instruments Corp. MAB Class II 2001-04-27
K002973 EMBOL-X INTRODUCER, MODEL CF00200 Embol-X, Inc. DYB Class II 2001-04-26
K004046 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. DTP Class II 2001-04-26
K002627 ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER Atrium Medical Corp. DXE Class II 2001-04-26
K010955 BMT ANSCORE HEALTH MANAGEMENT SYSTEM Boston Medical Technologies, Inc. DPS Class II 2001-04-26
K010451 NOVAMETRIX MARQUETTE COMPATIBLE SENSORS Novametrix Medical Systems, Inc. DQA Class II 2001-04-25
K003145 ORIGEN BLADDER HOLDER Origen Biomedical, Inc. DWC Class II 2001-04-20
K010880 NUMED HIGH PRESSURE PTA CATHETERS NuMED, Inc. DQY Class II 2001-04-20
K010531 ILT DEFLECTING CATHETER, MODEL C114ND1 Intra Luminal Therapeutics, Inc. DQY Class II 2001-04-18
K010853 GUIDER SOFTIP GUIDING CATHETER XF 5F Boston Scientific, Target DQY Class II 2001-04-18
K010822 AB CARDIETTE START 200 HV H&C Medical Devices Spa DPS Class II 2001-04-18
K002036 OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD Osi Medical, Inc. DQA Class II 2001-04-17
K010758 HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS Cambridge Heart, Inc. DPS Class II 2001-04-12
K010756 CH 2000 CARDIAC DIAGNOSTIC SYSTEM Cambridge Heart, Inc. DQK Class II 2001-04-12
K003731 SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc. DYB Class II 2001-04-10
K010164 ICG MODULE General Electric Medical Systems Information Techn DSB Class II 2001-04-09
K003542 PREAMP CABLE, MODEL B400-1011PA Beta Biomed Services, Inc. DQA Class II 2001-04-06
K010912 ALARMVIEW WIRELESS DATA NETWORK SYSTEM Data Critical Corp. MSX Class II 2001-04-05
K003701 SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) Sentech Medical Systems, Inc. JOW Class II 2001-04-05
K010906 MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 Medtronic Vascular DRB Class II 2001-04-05
K010737 SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 Medtronic Cardiac Surgical Products DWF Class II 2001-04-04
K010117 GUIDANT AXIUS CORONARY SHUNT Cardiothoracic Systems, Inc. DXC Class II 2001-04-04
K002019 RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET Sorin Group Italia S.R.L. DWF Class II 2001-03-30
K000814 FINGER PULSE METER Bhs Intl., Inc. DQA Class II 2001-03-29
K010828 DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP A&D Engineering, Inc. DXN Class II 2001-03-29
K010707 ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 Boston Scientific, Target DQO Class II 2001-03-29
K010622 PRESSURE TRAK, MODEL 222-B Suntech Medical Instruments, Inc. DXN Class II 2001-03-29
K004011 IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS Impra, Inc. DSY Class II 2001-03-27
K002869 LOCALISA CARDIAC NAVIGATION SYSTEM Medtronic Surgical Navigation Technologies DQK Class II 2001-03-27
K003723 3M LITTMANN 3M Company DQD Class II 2001-03-27
K001734 FOGARTY VALVULOTOME, MODEL 700091 Edwards Lifesciences, LLC MGZ Class II 2001-03-26
K010718 FLEXI-SITE SP02 EAR SENSOR Epic Medical Equipment Services, Inc. DPZ Class II 2001-03-23
K000977 COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS Olson Medical Sales, Inc. DTR Class II 2001-03-23
K002286 LDOB OCCLUSION BALLOON CATHETER Cook, Inc. MJN Class II 2001-03-22
K010497 SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 Micro Therapeutics, Inc. DQX Class II 2001-03-22
K010686 KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C Golden Horse Medical Equipment (Wuxi) Co. , Ltd. DXQ Class II 2001-03-21
K002507 TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc. DYB Class II 2001-03-21
K010498 WRISTWATCH BLOOD PRESSURE MONITOR A46 Rossmax Internationl , Ltd. DXN Class II 2001-03-20
K010640 SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER Siemens Medical Solutions USA, Inc. DRQ Class II 2001-03-20
K010482 ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 Echocath, Inc. JOP Class II 2001-03-20
K010642 PLEURX PLEURAL CATHETER AND DRAINAGE KITS Denver Biomedicals, Inc. DWM Class II 2001-03-20
K002665 WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120 K-Jump Health Co., Ltd. DXN Class II 2001-03-19
K002254 COOK PRESSURE MONITORING CATHETER Cook, Inc. DQO Class II 2001-03-16
K010463 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES Datex-Ohmeda, Inc. DQA Class II 2001-03-15
K004050 PANASONIC TELE-HOMECARE SYSTEM Matsushita Electric Industrial Co., Ltd. MWI Class II 2001-03-15
K992706 GALIX GBI -3S-LP Galix Biomedical Instrumentation, Inc. MLO Class II 2001-03-15
K010505 TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY Brentwood Medical Technology Corp. DPS Class II 2001-03-09
K010390 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS Acist Medical Systems, Inc. DXT Class II 2001-03-09
K002907 PVS 1300 NEURO GUIDE WIRE Precision Vascular Systems, Inc. DQX Class II 2001-03-08
K003998 FLEXVIEW CLINICAL MONITORING SYSTEM Data Critical Corp. MSX Class II 2001-03-07
K003085 CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 Concentric Medical, Inc. DQY Class II 2001-03-07
K010338 ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 Medivance, Inc. DWJ Class II 2001-03-07
K001856 SUPERCROSS CATHETER Abbott Vascular, Inc. DQY Class II 2001-03-07
K010419 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2001-03-06
K010330 ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U Arrow Intl., Inc. DSP Class II 2001-03-02
K004044 HOMMED SENTRY III PATIENT MONITOR SYSTEM Hommed, LLC DQA Class II 2001-03-02
K010453 M2376A DEVICELINK SYSTEM Agilent Technologies, Inc. MWI Class II 2001-03-02
K003362 ASTRONOMER+WITH SLD Boston Scientific Corp DQK Class II 2001-03-01
K001708 PROFOX SOFTWARE, MODEL 920M-41 Respironics Georgia, Inc. DQA Class II 2001-03-01
K010511 MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES Cordis Neurovascular, Inc. DQX Class II 2001-03-01
K003719 VASCULAR ARCHITECTS PERISCOPE DEVICE Vascular Architects, Inc. DWX Class II 2001-02-28
K010257 ZOLL M SERIES Zoll Medical Corp MKJ Class III 2001-02-28
K010261 CARDIOMEDICS ECP SYSTEM Cardiomedics, Inc. DRN Class II 2001-02-28
K010214 FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 Survivalink Corp. MKJ Class III 2001-02-22

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