meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
2002-02-06

Clearances · page 96 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K012606 CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE Clearmedical, Inc. JOW Class II 2002-02-06
K011540 VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 Datascope Corp. MHX Class II 2002-02-06
K011838 CENTRIFUGAL PUMP Stockert Instrumente GmbH DWA Class II 2002-02-05
K012274 MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER Medtronic Physio-Control Corp. LDD Class II 2002-02-05
K012861 VASCUPUNCTURE ACCESS WIRE Neometrics, Inc. DQX Class II 2002-02-05
K012241 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 Cardionet, Inc. DSI Class II 2002-02-01
K011901 FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 Survivalink Corp. MKJ Class III 2002-02-01
K013879 TM2000, MODEL 1 Card Guard Scientific Survival , Ltd. DXH Class II 2002-02-01
K020022 DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 Ge Medical Systems Information Technologies MWI Class II 2002-02-01
K014016 ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER Minntech Corp. DWC Class II 2002-02-01
K013354 GLOBALCARDIO Cardiocomm Solutions, Inc. DSH Class II 2002-01-31
K014299 SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH Sorba Medical Systems, Inc. DSB Class II 2002-01-30
K013725 MEDITRON II THESTERTHOSCOPE SYSTEM Meditron AS DQD Class II 2002-01-30
K020012 MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER Boston Scientific/Medi-Tech DQO Class II 2002-01-29
K012349 METAVISION CLINICAL INFORMATION SYSTEM Imdsoft, Ltd. MWI Class II 2002-01-29
K012089 CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM Catheffects, LLC DQK Class II 2002-01-28
K014223 MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM Medtronic Percusurge, Inc. NFA Class II 2002-01-25
K013577 ULTRAMAX WOVEN VELOUR VASCULAR GRAFT Atrium Medical Corp. DSY Class II 2002-01-25
K014294 MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 Medical Data Electronics DQA Class II 2002-01-25
K011783 MULTI-SNARE SET Pfm Produkte Fur Die Medizin AG DXE Class II 2002-01-24
K012534 HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Advanced Cardiovascular Systems, Inc. DQX Class II 2002-01-24
K012749 BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 Biocardia, Inc. DQO Class II 2002-01-24
K011826 EPS320 CARDIAC STIMULATOR Micropace Pty, Ltd. JOQ Class II 2002-01-24
K003889 ANCURE SHEATH MODEL # 40315, 40320, 40325 Guidant Cardiac and Vascular Surgery DYB Class II 2002-01-24
K010923 KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E Siemens Elema AB MHX Class II 2002-01-23
K012766 PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc. MKJ Class III 2002-01-23
K011625 VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) Vasocor, Inc. DXN Class II 2002-01-23
K013578 PUMP TUBING Terumo Cardiovascular Systems Corp. DWE Class II 2002-01-22
K012480 VANGUARD REPROCESSED INFLATION DEVICES Vanguard Medical Concepts, Inc. MAV Class II 2002-01-22
K020028 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX Boston Scientific DQY Class II 2002-01-22
K013533 EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) General Devices DRG Class II 2002-01-18
K014159 PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR Philips Medical Systems, Inc. DSI Class II 2002-01-18
K014209 PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS Padpro, LLC MKJ Class III 2002-01-18
K013485 MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 Microlife Corp. DXN Class II 2002-01-17
K013539 ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS Rossmax International , Ltd. DXN Class II 2002-01-17
K012759 INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 Hutchinson Technology, Inc. MUD Class II 2002-01-17
K014157 HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A Philips Medical Systems MKJ Class III 2002-01-17
K014212 BARD CONQUEST PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. DQY Class II 2002-01-17
K014213 SIEMENS INFINITY GATEWAY SUITE Siemens Medical Solutions USA, Inc. MHX Class II 2002-01-17
K012012 ECG HOME H&C Medical Devices Spa DXH Class II 2002-01-17
K013583 ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS Rossmax International , Ltd. DXN Class II 2002-01-17
K014122 HL168E Health & Life Co., Ltd. DXN Class II 2002-01-16
K014124 NUMED COEFFICIENT PTV CATHETERS NuMED, Inc. OMZ Class II 2002-01-16
K013833 HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 Guidant Corp. DQX Class II 2002-01-16
K011562 LUMEND PERCUTANEOUS CATHETER Lumend, Inc. DQY Class II 2002-01-16
K014181 M2376A DEVICELINK SYSTEM, MODEL M2376A Philips Medical Systems, Inc. MWI Class II 2002-01-15
K014161 SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) St. Jude Medical, Inc. KRH Class II 2002-01-15
K013425 HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A Philips Medical Systems MKJ Class III 2002-01-14
K013598 REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES C.R. Bard, Inc. DSA Class II 2002-01-11
K014121 WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 Nellcor Puritan Bennett, Inc. DWJ Class II 2002-01-11
K014118 MODIFICATION TO SUPERCROSS CATHETER Abbott Vascular, Inc. DQY Class II 2002-01-11
K014117 MODIFICATION TO OUTBACK CATHETER Lumend, Inc. DQY Class II 2002-01-11
K013515 INFINITY EXPLORER Siemens Medical Solutions USA, Inc. DXJ Class II 2002-01-10
K014108 MAC 5000 ECG ANALYSIS SYSTEM General Electric Medical Systems Information Techn DQK Class II 2002-01-10
K013478 DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM Pulse Metric, Inc. DXN Class II 2002-01-10
K013387 DATEX-OHMEDA S/5 WEB VIEWER Datex-Ohmeda MSX Class II 2002-01-08
K014080 APEX ADULT HOLLOWE FIBER OXYGENATOR Dideco S.P.A. DTZ Class II 2002-01-08
K014037 SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) St. Jude Medical, Inc. KRH Class II 2002-01-04
K013601 NUMED MULLINS PTA CATHETER NuMED, Inc. DQY Class II 2002-01-03
K011564 NEOLEAD Neotech Products, Inc. DRX Class II 2002-01-03
K013171 3420 DIGIT PULSE OXIMETER, MODEL 3420 Bci, Inc. DQA Class II 2002-01-03
K013319 NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR Nonin Medical, Inc. DQA Class II 2002-01-03
K013311 MODIFICATION TO: POCKETVIEW ECG SOFTWARE Micromedical Industries, Ltd. MHX Class II 2002-01-03
K013915 D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER Dideco S.P.A. DTZ Class II 2001-12-27
K011832 VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE Vanguard Medical Concepts, Inc. NMF Class II 2001-12-21
K013436 NORMATEC PCD Normatec, Inc. JOW Class II 2001-12-21
K011889 ULTRA -THIN SDS BALLOON DILATATION CATHETER Boston Scientific Corp DQY Class II 2001-12-21
K013273 FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE Fukuda Denshi USA, Inc. DQA Class II 2001-12-20
K012256 GELBISH VASCULAR DILATOR Vascumetrix, LLC DRE Class II 2001-12-20
K013019 DATACAPTOR Capsule Technologie MWI Class II 2001-12-18
K011907 SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM Sims Level 1, Inc. DWJ Class II 2001-12-18
K013943 RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 Radi Medical Systems AB DSK Class II 2001-12-18
K013939 JOSTRA FLOWPROBE FP-32E Jostra AG DPT Class II 2001-12-14
K013358 DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM Pulse Metric, Inc. DXN Class II 2001-12-13
K013092 HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. DQX Class II 2001-12-13
K013367 CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH Reynolds Medical , Ltd. DPS Class II 2001-12-13
K013815 MEDRAD QWIK-FIT SYRINGE Medrad, Inc. DXT Class II 2001-12-13
K010526 MODIFICATION TO THE GRIP Elcare Innovations, Inc. LIX Class II 2001-12-13
K012686 CAIRD TECHNOLOGY HOLTER 2000 Caird Technology DPS Class II 2001-12-13
K013792 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2001-12-11
K010443 CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING Terumo Cardiovascular Systems Corp. DTZ Class II 2001-12-11
K013246 DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 Datex-Ohmeda MSX Class II 2001-12-11
K013789 EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 Boston Scientific, Target DQY Class II 2001-12-06
K013638 MODIFICATION TO VIKING OPTIMA GUIDING CATHETER Guidant Corp. DQY Class II 2001-12-04
K013024 SELECTIVA GUIDEWIRE Neometrics, Inc. DQX Class II 2001-12-04
K013013 MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. Medtronic Cardiac Surgical Products DWF Class II 2001-12-04
K011144 LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp. MKJ Class III 2001-12-03
K013624 MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I Philips Medizin Systeme Boblingen GmbH MHX Class II 2001-12-03
K013331 LYMPHA PRESS PLUS DEVICE Mego Afek JOW Class II 2001-11-30
K013427 MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A Philips Medical Systems, Inc. MHX Class II 2001-11-29
K013581 CORDIS AVIATOR PERIPHERAL DILATATION CATHETER Cordis, A Johnson & Johnson Co. DQY Class II 2001-11-28
K013199 PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B Philips Medical Systems, Inc. MHX Class II 2001-11-28
K011192 COMPRESSIBLE LIMB SLEEVE Alliance Medical Corp. JOW Class II 2001-11-26
K013083 CARTO XP EP NAVIGATION SYSTEM Biosense Webster, Inc. DQK Class II 2001-11-21
K013564 MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS Cambridge Heart, Inc. DPS Class II 2001-11-21
K010579 STENT SUPPORT GUIDE CATHETER Medtronic Vascular DQY Class II 2001-11-21
K013565 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 Cambridge Heart, Inc. DPS Class II 2001-11-21
K012854 RENAL GUIDING SHEATH Terumo Medical Corp. DYB Class II 2001-11-21
K011487 CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS Somanetics Corp. DXZ Class II 2001-11-21
K012197 POWERHEART CARDIAC RHYTHM MODULE Cardiac Science, Inc. MKJ Class III 2001-11-16

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