meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
51
Latest Decision
2001-11-16

Clearances · page 97 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K012774 JOSTRA ARTERIAL PERFUSION CANNULAE Jostra AG DWF Class II 2001-11-16
K013480 COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. DTZ Class II 2001-11-16
K013526 CAPIOX RX HARDSHELL RESERVOIR Terumo Cardiovascular Systems Corp. DTN Class II 2001-11-15
K012763 SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM Cobe Cardiovascular, Inc. DRT Class II 2001-11-15
K012812 CAROTID GUIDING SHEATH Terumo Medical Corp. DYB Class II 2001-11-14
K012801 N2000 BASE STATION, N2001 NURSE STATION Neptec Design Group, Ltd. DXN Class II 2001-11-14
K013470 MODIFICATION TO M2376A DEVICELINK SYSTEM Philips Medical Systems, Inc. MWI Class II 2001-11-14
K012647 TONOPORT V Par Medizintechnik GmbH DXN Class II 2001-11-09
K013393 HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H A-Med Systems, Inc. KFM Class II 2001-11-09
K013339 PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS Oscor, Inc. DTB Class III 2001-11-08
K011652 BODY FAT ANALYZER, MODEL HBF-306 Omron Healthcare, Inc. MNW Class II 2001-11-07
K011899 PF 5050 PRESSURE UNIT, MODEL PF 5050 Perimed AB DPW Class II 2001-11-06
K012617 JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... Jostra AG DWF Class II 2001-11-06
K012942 THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 Circulatory Technology, Inc. DTN Class II 2001-11-05
K012626 OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR Osi Medical, Inc. DQA Class II 2001-11-02
K013326 MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B Datascope Corp. DSP Class II 2001-11-02
K012531 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX Datex-Ohmeda MSX Class II 2001-11-02
K011439 MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR Cardiodynamics International Corp. DSB Class II 2001-11-02
K012498 DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM Pulse Metric, Inc. DXN Class II 2001-11-01
K012304 ADC 656 ELECTRONIC STETHOSCOPE American Diagnostic Corp. DQD Class II 2001-11-01
K011761 MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc. DYB Class II 2001-10-31
K013175 TM2000 EASYTRACE PLUS RECEIVING CENTER Card Guard Scientific Survival , Ltd. DXH Class II 2001-10-30
K001509 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE Cobe Cardiovascular, Inc. DWF Class II 2001-10-26
K012636 BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 Vsm Technology, Inc. DXN Class II 2001-10-26
K011365 VITALSAT PULSE OXIMETER, MODEL IC32000 Island Critical Care Corp. DQA Class II 2001-10-26
K010729 AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A Andromed, Inc. DQD Class II 2001-10-26
K013250 GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 2001-10-26
K012141 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE External Counterpulsation Lab DRN Class II 2001-10-25
K011046 AUTOPULSE, MODEL 100 Revivant Corp. DRM Class II 2001-10-25
K011318 VENODYNE DVT ADVANTAGE PLUS Microtek Medical, Inc. JOW Class II 2001-10-25
K012143 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 Medtronic Cardiac Surgical Products DRA Class II 2001-10-24
K011056 ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD Arrow Intl., Inc. QEW Class II 2001-10-24
K011058 TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII Meridian Medical Technologies , Ltd. DXN Class II 2001-10-23
K013033 MODIFICATION TO: HL168W TOUCH SCREEN Health & Life Co., Ltd. DXN Class II 2001-10-23
K013202 MODIFICATION TO BRAIDED GUIDING INTRODUCER Thomas Medical Products, Inc. DYB Class II 2001-10-23
K013156 MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM Data Critical Corp. MSX Class II 2001-10-19
K003857 STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES Sterilmed, Inc. JOW Class II 2001-10-18
K012333 FLEXI-SITE SP02 EAR SENSOR Epic Medical Equipment Services, Inc. DPZ Class II 2001-10-17
K012403 VANGUARD REPROCESSED COMPRESSION GARMENT Vanguard Medical Concepts, Inc. JOW Class II 2001-10-17
K012218 LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES The Ludlow Company LP DRO Class II 2001-10-12
K011373 INSTRUMENT DAMPING PORT Medcanica, Inc. DRC Class II 2001-10-12
K012404 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 Katecho, Inc. DRO Class II 2001-10-12
K012206 ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM Cambridge Heart, Inc. DQK Class II 2001-10-12
K012264 MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC National Custom Ent., Inc. DPS Class II 2001-10-10
K012263 MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 National Custom Ent., Inc. DPS Class II 2001-10-10
K013029 SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 St Jude Medical DYB Class II 2001-10-09
K010954 CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 Concentric Medical, Inc. DQY Class II 2001-10-09
K011349 INTERCOSTAL LOCKABLE-DIRECTABLE PORT Medcanica, Inc. DRC Class II 2001-10-05
K010706 THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER Measurement Specialties, Inc. MNW Class II 2001-10-05
K010396 C. NET 2100 Cardionetics, Ltd. MLO Class II 2001-10-04
K012950 MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM Medrad, Inc. DXT Class II 2001-10-04
K004001 MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR Dideco DTZ Class II 2001-10-04
K012336 MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 Medical Data Electronics DSI Class II 2001-10-03
K012992 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2001-10-03
K012947 SMARTFLOW Florence Medical , Ltd. DQK Class II 2001-10-02
K012952 HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT Boston Scientific/Medi-Tech DSY Class II 2001-10-02
K012913 BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. DQY Class II 2001-09-28
K010949 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies MLO Class II 2001-09-28
K012428 MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp. MKJ Class III 2001-09-28
K012926 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. MTD Class II 2001-09-28
K010913 VYGON SPLIT CANNULA INTRODUCER Vygon Corp. DYB Class II 2001-09-28
K013084 AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T Medtronic Perfusion Systems DTM Class II 2001-09-27
K010732 VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) Telemedic Systems, Inc. MWI Class II 2001-09-27
K010478 DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR Dideco DTZ Class II 2001-09-27
K012540 BLY-501 ADAPTOR Micromedical Industries, Ltd. DPS Class II 2001-09-26
K012922 ULTRAFLEX EV HEMOSTASIS INTRODUCER St Jude Medical DYB Class II 2001-09-25
K012030 PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc. MKJ Class III 2001-09-24
K012008 STS RANGE , MODELS STS20,STS30,STS40 Huntleigh Healthcare, Inc. JOW Class II 2001-09-21
K012098 PRECLUDE PERICARDIAL MEMBRANE W. L. Gore & Associates, Inc. DXZ Class II 2001-09-20
K012898 MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM Cobe Cardiovascular, Inc. DTR Class II 2001-09-17
K011898 E-STETH ELECTRONIC STETHOSCOPE E-Med Innovations, Inc. DQD Class II 2001-09-14
K012837 MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES Datex-Ohmeda MLD Class II 2001-09-14
K012743 TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T Medtronic Perfusion Systems DRY Class II 2001-09-14
K012747 TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) Medtronic Perfusion Systems DPT Class II 2001-09-14
K011980 ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 Pace Medical DTE Class II 2001-09-12
K011918 NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES Nihon Kohden America, Inc. MHX Class II 2001-09-12
K012223 CG-2211 SELFCHECK ECG TRANSMITTER Card Guard Scientific Survival , Ltd. DXH Class II 2001-09-10
K011664 IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific/Medi-Tech DQO Class II 2001-09-07
K012050 VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Guidant Corp. DQY Class II 2001-09-06
K011361 DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE Catheffects, LLC DRF Class II 2001-09-06
K011790 MICROCRUISER PLUS INTRODUCER SET Medical Device Technologies, Inc. DYB Class II 2001-09-05
K003548 PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS Padpro, LLC MKJ Class III 2001-09-04
K012392 DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 Pace Medical DSA Class II 2001-09-04
K010424 NEXAN SYSTEM, MODEL NX-301 Nexan, Ltd. MWI Class II 2001-09-04
K003804 SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 Niko Medical Products DRX Class II 2001-08-30
K012169 ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 Intra Luminal Therapeutics, Inc. DQY Class II 2001-08-30
K011729 SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 Dni Nevada, Inc. DTC Class II 2001-08-30
K012489 MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 Appriva Medical, Inc. DYB Class II 2001-08-30
K012130 ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM Medtronic Vascular DQY Class II 2001-08-28
K012083 ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 Medtronic Vascular DQY Class II 2001-08-28
K011905 SNIPER ELITE MODEL-OR-E3872XX SERIES Maxxim Medical DQX Class II 2001-08-28
K012225 ATTAIN 6215 VENOGRAM BALLOON CATHETER Medtronic Vascular DYG Class II 2001-08-28
K011646 NEUROEDGE INFUSION CATHETER Neuro Vasx, Inc. KRA Class II 2001-08-27
K012538 TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE Medtronic Vascular DWF Class II 2001-08-23
K010918 LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM Medtronic Physio-Control Corp. MKJ Class III 2001-08-23
K011811 MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE Merit Medical Systems, Inc. DXT Class II 2001-08-22
K012310 MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR Health & Life Co., Ltd. DXN Class II 2001-08-22
K012533 MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES Osi Medical, Inc. DQA Class II 2001-08-22
K011991 MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR Medrad, Inc. DXT Class II 2001-08-21
K010785 KSEA DION-GRACIA SET KARL STORZ Endoscopy-America, Inc. DXC Class II 2001-08-21

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