meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
2001-08-21

Clearances · page 98 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K012020 RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC Non-Invasive Monitoring Systems, Inc. DQK Class II 2001-08-21
K011660 WECK CARDIAC PACING WIRES Weck Closure Systems LDF Class II 2001-08-21
K011339 QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 Spacelabs Burdick, Inc. DSI Class II 2001-08-20
K012451 PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 Welch Allyn Protocol, Inc. DRT Class II 2001-08-20
K012455 WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM Welch Allyn, Inc. DXQ Class II 2001-08-17
K012553 GSIBP BLOOD PRESSURE CUFF Globalshop, Inc. DXQ Class II 2001-08-17
K012461 SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER Siemens Medical Solutions USA, Inc. DSI Class II 2001-08-17
K011784 MODIFICATION TO ENVOY PATIENT MONITOR Mennen Medical , Ltd. DSI Class II 2001-08-16
K012444 ABN ANEROID SPHYGMOMANOMETER Pt. Sugih Instrumendo Abadi DXQ Class II 2001-08-16
K001245 3T L. V. CONTROL VALVE 3t Medical Systems, LLC MJJ Class II 2001-08-15
K012209 CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X Terumo Cardiovascular Systems Corp. KFM Class II 2001-08-15
K012452 MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD Medtronic Vascular LDF Class II 2001-08-14
K012459 MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE Medtronic Vascular LDF Class II 2001-08-14
K012187 CG-3250 MINIRECEIVER Card Guard Scientific Survival , Ltd. DXH Class II 2001-08-14
K012454 MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD Medtronic Vascular LDF Class II 2001-08-14
K012460 MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD Medtronic Vascular LDF Class II 2001-08-14
K012458 MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD Medtronic Vascular LDF Class II 2001-08-14
K012407 PACEART TX3 CARDIAC EVENT RECORDER Paceart, Inc. DXH Class II 2001-08-14
K011906 BACK-UP MEIER GUIDEWIRE Boston Scientific Corp DQX Class II 2001-08-13
K012248 CHASE CARDIOVASCULAR PATCH Chase Medical, Inc. DXZ Class II 2001-08-10
K011320 ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM Hitachi Medical Systems America, Inc. DQA Class II 2001-08-09
K012054 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 Sein Electronics Co., Ltd. DXN Class II 2001-08-08
K011535 CADENCE PRECISION INJECTOR, MODEL 103-0304 Micro Therapeutics, Inc. MJN Class II 2001-08-02
K010413 MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI Konica Minolta Sensing, Inc. DQA Class II 2001-08-02
K012059 8100/8500 VITAL SIGNS MONITOR Criticare Systems, Inc. MWI Class II 2001-08-01
K011865 ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION Zoll Medical Corp DSK Class II 2001-07-31
K012035 BRAUN PRECISION SENSOR PRO, MODEL BP 2590 Braun GmbH DXN Class II 2001-07-27
K012002 VIKING OPTIMA GUIDING CATHETER Guidant Corp. DQY Class II 2001-07-26
K011968 STREERABLE PTCA GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2001-07-25
K012005 MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM Data Critical Corp. MSX Class II 2001-07-24
K012171 MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS Visicu, Inc. MSX Class II 2001-07-24
K011999 MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM Data Critical Corp. MSX Class II 2001-07-24
K011345 CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM Reynolds Medical , Ltd. DXH Class II 2001-07-20
K012094 MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. MWI Class II 2001-07-20
K012194 BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 Nihon Seimitsu Sokki Co., Ltd. DXQ Class II 2001-07-20
K011539 ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS Rossmax International , Ltd. DXN Class II 2001-07-20
K011352 ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS Rossmax International , Ltd. DXN Class II 2001-07-20
K011310 NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 Nien Made Electrnics Corp. DXN Class II 2001-07-20
K012016 INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II Siemens Medical Solutions USA, Inc. MHX Class II 2001-07-20
K004025 SPLITTABLE SHEATH INTRODUCER KIT Thomas Medical Products, Inc. DYB Class II 2001-07-19
K011837 LIFECARD CF 7 DAY Reynolds Medical , Ltd. MWJ Class II 2001-07-13
K011078 MALLEABLE SHAFT CLAMP Allegiance Healthcare Corp. DXC Class II 2001-07-13
K011779 AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM Avid Care Corp. DXN Class II 2001-07-13
K011847 ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE Zynergy Cardio Vasular (Zcv), Inc. DRF Class II 2001-07-13
K012013 LIFESOURCE MODELS UA-787, UA 787PC, UA-787T A&D Engineering, Inc. DXN Class II 2001-07-13
K011395 MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B Medtronic Vascular KRH Class II 2001-07-12
K011557 PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NuMED, Inc. DXF Class II 2001-07-12
K011851 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2001-07-11
K003551 VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 Jostra AG DTN Class II 2001-07-11
K011864 TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B Medtronic Vascular DTN Class II 2001-07-09
K011085 GUIDEWIRE INTRODUCER SAFETY NEEDLE Medamicus, Inc. DYB Class II 2001-07-09
K004026 BRAIDED GUIDING INTRODUCER Thomas Medical Products, Inc. DYB Class II 2001-07-09
K011804 CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X Terumo Cardiovascular Systems Corp. DTM Class II 2001-07-09
K011436 MOBILE-PATIENT VIEWER Data Critical Corporation DPS Class II 2001-07-05
K011797 BIOZTECT SENSOR AND BIOZTECT CABLE Cardiodynamics International Corp. DSB Class II 2001-07-03
K002835 BODYSTAT Bodystat , Ltd. MNW Class II 2001-07-03
K011734 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX Mogul Enterprises DRF Class II 2001-07-03
K011766 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 St Jude Medical DRF Class II 2001-07-03
K011824 AGILENT M2636B TELEMON B MONITOR (TELEMON B) Agilent Technologies, Inc. DSI Class II 2001-07-02
K011000 TRAM 2001 MODULE General Electric Medical Systems Information Techn MHX Class II 2001-06-29
K010029 HOME HEALTH MONITORING SYSTEM Avid Care Corp. DXN Class II 2001-06-29
K003180 HOMMED OBSERVER, MODEL I Hommed, LLC DXN Class II 2001-06-28
K003999 AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 American Telecare, Inc. MWI Class II 2001-06-28
K011831 MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS Denver Biomedical, Inc. DWM Class II 2001-06-28
K011670 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE Datex-Ohmeda DQA Class II 2001-06-26
K010838 FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 Jomed AG DQY Class II 2001-06-21
K010874 6F MACH 1, MODEL 34356-XXX Boston Scientific Corp DQY Class II 2001-06-21
K011656 HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 Micro Therapeutics, Inc. MJN Class II 2001-06-20
K010974 RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET Sorin Group Italia S.R.L. DWF Class II 2001-06-18
K003920 CORDIS M3 PTA DILATATION CATHETER Cordis Corp. DQY Class II 2001-06-15
K011526 HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 Micro Therapeutics, Inc. MJN Class II 2001-06-14
K010049 PULSECO HEMODYNAMIC MONITOR CM71 Lidco, Ltd. DXG Class II 2001-06-14
K010207 PORTABLE INSTENSIVE CARE UNIT Medical Research Laboratories, Inc. MKJ Class III 2001-06-14
K011523 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 Rossmax International , Ltd. DXN Class II 2001-06-14
K010055 COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH Cook Vascular, Inc. DRE Class II 2001-06-14
K011156 BCI 3403 SLEEP SCREENING PULSE OXIMETER Bci, Inc. DQA Class II 2001-06-14
K011464 RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN Vascular Intervention DQY Class II 2001-06-13
K010831 AVIATOR PERIPHERAL DILATATION CATHETER Guidant Corp. DQY Class II 2001-06-13
K010945 HEARTCARD, MODEL 5258 Instromedix DXH Class II 2001-06-12
K010770 BCI ADVISOR VITAL SIGNS MONITOR (9200) Bci, Inc. MWI Class II 2001-06-12
K004017 H-SCRIBE Mortara Instrument, Inc. MLO Class II 2001-06-11
K010751 BPFONE, MODEL UA 767IT Medical Monitors Pty Limited DXN Class II 2001-06-11
K010634 HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B Agilent Technologies, Inc. MKJ Class III 2001-06-11
K010186 WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM Welch Allyn, Inc. DXN Class II 2001-06-08
K010966 MEDLEY SP02 MODULE, MODEL 8220 Alaris Medical Systems, Inc. DQA Class II 2001-06-08
K003288 ORIGEN DUAL LUMEN CATHETER Origen Biomedical, Inc. DQO Class II 2001-06-08
K010791 REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) Adsis , Ltd. DXH Class II 2001-06-08
K011578 M2376A DEVICELINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. MWI Class II 2001-06-08
K003937 CPR EZY MASK AND PAD Medteq Innovations Pty, Ltd. LIX Class II 2001-06-06
K010083 TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A Cordis Corp. DTK Class II 2001-06-06
K001917 PARODI CATHETER FOR ANGIOGRAPHY (PARCA) Arteria Medical Science, Inc. MJN Class II 2001-06-06
K010471 AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 Irvine Biomedical, Inc. DRF Class II 2001-06-06
K003570 BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 Bacchus Vascular, Inc. MCW Class II 2001-06-06
K010473 SPARROWHAWK DISPOSABLE Atc Technologies, Inc. DWZ Class II 2001-06-06
K003992 PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM Percu Surge, Inc. NFA Class II 2001-06-01
K011152 VASOTRAC APM205A Medwave, Inc. DXN Class II 2001-05-31
K002514 CADHEALTH SYSTEM, MODEL CHP-001 Caduceus Health Care , Ltd. DRG Class II 2001-05-31
K002847 INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX Maxxim Medical DYB Class II 2001-05-31
K011287 RADIUS COUGAR WIRE Radius Medical Technologies, Inc. DQX Class II 2001-05-25
K002848 SPO2 WRAP SENSOR Epic Medical Equipment Services, Inc. DQA Class II 2001-05-24

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