meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
39
Latest Decision
2002-04-23

Clearances · page 95 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K020604 WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 Nellcor Puritan Bennett, Inc. DWJ Class II 2002-04-23
K021051 ANNULOFLO SYSTEM, MITRAL MODEL AR700 Sulzer Carbomedics, Inc. KRH Class II 2002-04-23
K020184 HOMMED CENTRAL STATION Hommed, LLC DXN Class II 2002-04-22
K021213 MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS Boston Scientific Corp MAL Class II 2002-04-19
K020890 SPYGLASS 4 FR ANGIOGRAPHICY CATHETER St Jude Medical DQO Class II 2002-04-17
K020864 EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 Edwards Lifesciences, LLC KRH Class II 2002-04-17
K012657 HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP Hygia Health Services, Inc. JOW Class II 2002-04-12
K012654 HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 Hygia Health Services, Inc. JOW Class II 2002-04-12
K012651 HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200 Hygia Health Services, Inc. JOW Class II 2002-04-12
K021029 ABP-2000 G-3 Biotrac, Inc. DXN Class II 2002-04-12
K012650 HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP Hygia Health Services, Inc. JOW Class II 2002-04-12
K011903 LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE Vivometrics, Inc. DQK Class II 2002-04-12
K012956 HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB Hygia Health Services, Inc. JOW Class II 2002-04-11
K002578 AXILLARY ACCESS ARTERIAL CANNULA Edwards Lifesciences, LLC DWF Class II 2002-04-11
K011541 ZOLL PAD WITH CPR AID Zoll Medical Corp MKJ Class III 2002-04-11
K020854 MODIFICATION TO FOX PTA CATHETER Jomed AG LIT Class II 2002-04-11
K020106 VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER Gish Biomedical, Inc. DTR Class II 2002-04-10
K012325 CARDIOVENTION CORX SYSTEM, MODEL FG 0001 Cardiovention, Inc. KFM Class II 2002-04-09
K010281 MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP Biotronik, Inc. DTB Class III 2002-04-09
K013349 ASTRONOMER PLUS SYSTEM Ep Technologies, Inc. DQK Class II 2002-04-09
K014025 HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER Hommed, LLC DQA Class II 2002-04-09
K012417 HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 Hygia Health Services, Inc. JOW Class II 2002-04-08
K012226 MONITORING SYSTEM,MODEL ARGUS PB-1000 Schiller AG MHX Class II 2002-04-08
K020825 KING OF HEARTS EXPRESS + AF MONITOR Card Guard Scientific Survival , Ltd. DSH Class II 2002-04-05
K020766 HL168F Health & Life Co., Ltd. DXN Class II 2002-04-05
K020213 NETLINK/NETSCAN Rozinn Electronics, Inc. DXH Class II 2002-04-05
K020997 APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Dideco S.P.A. DTZ Class II 2002-04-04
K020998 SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X Terumo Cardiovascular Systems Corp. KFM Class II 2002-04-04
K020767 ADVANTA SST BIFURCATED GRAFT Atrium Medical Corp. DSY Class II 2002-04-03
K011986 SAFE-STEER GUIDE WIRE SYSTEM Intra Luminal Therapeutics, Inc. DQX Class II 2002-04-03
K020669 PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB Oscor, Inc. DTB Class III 2002-03-28
K012041 THE HAMMER MODEL H100 Tenacore Holdings, Inc. DXC Class II 2002-03-28
K020680 PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS Cordis Neurovascular, Inc. KRA Class II 2002-03-27
K012994 WIZAIR DVT Medical Compression Systems (Dbn) , Ltd. JOW Class II 2002-03-27
K012520 GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E Cardiac Assist Devices, Inc. DRF Class II 2002-03-27
K010744 FLOWTRON UNIVERSAL, MODEL AC600 Huntleigh Healthcare, Inc. JOW Class II 2002-03-26
K020479 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES Datex-Ohmeda DQA Class II 2002-03-26
K014303 JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE Jostra AG DWF Class II 2002-03-26
K014262 COSMED QUARK C12/QUARK T12 Cosmed Srl DPS Class II 2002-03-26
K011388 ZOLL PAD Zoll Medical Corp MKJ Class III 2002-03-25
K012915 DINAMAP PRO 1000 MONITOR, MODEL 1000 Ge Medical Systems Information Technologies MHX Class II 2002-03-21
K020733 PVS 1500 SDS Precision Vascular Systems, Inc. KRA Class II 2002-03-21
K012989 DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 Dolphin Medical, Inc. DQA Class II 2002-03-20
K020524 PATIENTNET MONITORING SYSTEM General Electric Medical Systems Information Techn MSX Class II 2002-03-20
K020531 PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B Philips Medical Systems MHX Class II 2002-03-20
K020316 CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU Cordis Corp. DQO Class II 2002-03-20
K010253 ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 Transonic Systems, Inc. DYG Class II 2002-03-19
K012825 HEARTTRENDS Lev-El, Ltd. DQK Class II 2002-03-19
K020632 ENGUARD REMOTE PATIENT MONITOR Mennen Medical , Ltd. QYX Class II 2002-03-15
K012796 AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 Amluck, Inc. DXN Class II 2002-03-14
K020233 CHASE CARDIOVASCULAR PATCH KIT Chase Medical, Inc. DXZ Class II 2002-03-14
K012983 ACIST 4 FRENCH ANGIOGRAPHIC CATHETER Acist Medical Systems, Inc. DQO Class II 2002-03-13
K014109 IN-TIME RETRIEVAL DEVICE Boston Scientific, Target MMX Class II 2002-03-12
K014054 EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL Edwards Lifesciences, LLC DQO Class II 2002-03-08
K014052 EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL Edwards Lifesciences, LLC DYB Class II 2002-03-08
K014075 BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 Baylis Medical Co., Inc. DQX Class II 2002-03-07
K012891 OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) Nellcor Puritan Bennett, Inc. DQA Class II 2002-03-07
K012414 PRIME ECG SYSTEM Meridian Medical Technologies, Inc. DPS Class II 2002-03-06
K013473 XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL Xtrak Medical, Inc. MCW Class II 2002-03-06
K014204 ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 K-Jump Health Co., Ltd. DXN Class II 2002-03-05
K020340 MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. DQX Class II 2002-03-01
K013963 MODEL 9210 DELIVERY CATHETER, MODEL 9210 Medtronic Vascular DQY Class II 2002-02-28
K013651 INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS Intervascular DSY Class II 2002-02-27
K020288 PADPRO, MODEL 2603 Padpro, LLC MKJ Class III 2002-02-27
K020351 D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR Dideco S.P.A. DTZ Class II 2002-02-26
K020132 CHASE CARDIOVASCULAR PATCH KIT Chase Medical, Inc. DXZ Class II 2002-02-26
K020161 AGILTRAC .018 PERIPHERAL DILATATION CATHETER Guidant Corp. DQY Class II 2002-02-22
K020197 MODIFICATION TO DATACAPTOR Capsule Technologie MWI Class II 2002-02-21
K012487 SPHYGMOCOR PX MODEL SCOR-PX Atcor Medical Pty, Ltd. DXN Class II 2002-02-21
K020018 MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE Cardiopulmonary Corp. MSX Class II 2002-02-21
K020494 MODIFICATION TO M2376A DEVICELINK SYSTEM Philips Medical Systems, Inc. MWI Class II 2002-02-21
K013862 BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM Bci, Inc. DQA Class II 2002-02-21
K020277 SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER Siemens Medical Solutions USA, Inc. DRQ Class II 2002-02-19
K011863 VCS-A SERIES CLAMP Vascular Control Systems, Inc. DXC Class II 2002-02-15
K012472 A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS A&D Engineering, Inc. DXN Class II 2002-02-15
K020144 SIEMENS INFINITY SC 6002XL MODIFICATIONS Siemens Medical Solutions USA, Inc. DRT Class II 2002-02-15
K020127 SMARTFLOW PULSE TRANSMISSION COEFFICIENT Florence Medical , Ltd. DQK Class II 2002-02-14
K013803 FLOWGUARD DEVICE Biosonix , Ltd. DPW Class II 2002-02-13
K012675 REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS Adven Medical JOW Class II 2002-02-12
K011835 COBE REVOLUTION Cobe Cardiovascular, Inc. KFM Class II 2002-02-12
K010452 BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T Koven Technology, Inc. DPW Class II 2002-02-12
K011974 SENSAID Sensidyne, Inc. DQA Class II 2002-02-12
K014261 ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 Philips Medical Systems, Inc. MHX Class II 2002-02-12
K013284 LUMEND FRONTRUNNER CTO CORONARY CATHETER Lumend, Inc. DQY Class II 2002-02-11
K010694 INCLUDER CLAMP Novare Surgical Systems, Inc. DXC Class II 2002-02-11
K020090 MODIFICATION TO TRANSSEPTAL INTRODUCER SET Thomas Medical Products, Inc. DYB Class II 2002-02-11
K013635 TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) Bacchus Vascular, Inc. QEY Class II 2002-02-11
K012467 SOLAR 8000M SYSTEM General Electric Medical Systems Information Techn DSI Class II 2002-02-11
K020283 BACK-UP MEIER STEERABLE GUIDEWIRE Boston Scientific Corp DQX Class II 2002-02-11
K012597 STERILMED REPROCESSED COMPRESSION SLEEVES Sterilmed, Inc. JOW Class II 2002-02-11
K013944 JOSTRA DUAL STAGE VENOUS RETURN CANNULAE Jostra AG DWF Class II 2002-02-11
K020075 MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER Dolphin Medical, Inc. DQA Class II 2002-02-08
K002604 CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM Invivo Research, Inc. DSI Class II 2002-02-07
K014063 TASK FORCE MONITOR 3040 Cnsystems Medizintechnik GmbH DSB Class II 2002-02-07
K012601 CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH Clearmedical, Inc. JOW Class II 2002-02-06
K012621 CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT Clearmedical, Inc. JOW Class II 2002-02-06
K012612 CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE Clearmedical, Inc. JOW Class II 2002-02-06
K012616 CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR Clearmedical, Inc. JOW Class II 2002-02-06
K013717 BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY Brentwood Medical Technology Corp. DPS Class II 2002-02-06
K020084 FUKUDA DENSHI DYNASCOPE MODEL DS-5700 Fukuda Denshi USA, Inc. DSI Class II 2002-02-06

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