meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
2000-02-28

Clearances · page 104 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993036 ZOLL M SERIES ETCO2 OPTION Zoll Medical Corp MKJ Class III 2000-02-28
K000430 AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 Medtronic Vascular DTZ Class II 2000-02-25
K994229 VERIPATH PERIPHERAL GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 2000-02-25
K994044 CLEEN-ABLE Vital Signs, Inc. DXQ Class II 2000-02-25
K992638 DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 Critikon Company, LLC MWI Class II 2000-02-24
K000210 MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT Medtronic Vascular DTD Class II 2000-02-23
K993979 MARSPO2, MODEL 2001 Novametrix Medical Systems, Inc. DQA Class II 2000-02-22
K993974 SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR Siemens Medical Solutions USA, Inc. MHX Class II 2000-02-22
K992940 LEMAITRE BALLOON CATHETER WITH IRRIGATION Vascutech, Inc. DXE Class II 2000-02-22
K992657 IBC VRV, MODEL 1350 International Biophysics Corp. DWD Class II 2000-02-18
K993966 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER Arrow Intl., Inc. DSP Class II 2000-02-18
K000119 SJM TAILOR ANNULOPLASTY RING, MODEL TARN St. Jude Medical, Inc. KRH Class II 2000-02-17
K991737 LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR Dideco S.P.A. DTZ Class II 2000-02-17
K000379 MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 Medtronic Vascular DTM Class II 2000-02-16
K981936 ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION Advanced Biomedical Devices, Inc. DQX Class II 2000-02-16
K983928 KODAK HOME HEALTH MONITORING SYSTEM Eastman Kodak Company MWI Class II 2000-02-11
K000225 CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 Card Guard Scientific Survival , Ltd. DXH Class II 2000-02-11
K000274 EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE Medtronic Cardiac Surgical Products DWF Class II 2000-02-10
K000101 RX VIATRAC 14 PERIPHERAL DILATATION CATHETER Guidant Corp. LIT Class II 2000-02-10
K993818 ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE California Medical Laboratories, Inc. DWF Class II 2000-02-08
K993383 HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B Hewlett-Packard GmbH DSI Class II 2000-02-03
K993745 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 Katecho, Inc. MKJ Class III 2000-02-03
K992273 HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B Hewlett-Packard GmbH MHX Class II 2000-01-28
K993667 SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS Sulzermedica DSY Class II 2000-01-28
K993639 RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER Guidant Corp. LIT Class II 2000-01-27
K993533 POWERHEART AECD Cardiac Science, Inc. MKJ Class III 2000-01-24
K994331 REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR Medtronic Vascular MXC Class II 2000-01-21
K991545 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK Industrielle Entwicklung Medizintechnik Und Vertri DXQ Class II 2000-01-19
K984083 MULTIFUNCTION KEITO K5 Bumedco Intl., Inc. DXN Class II 2000-01-18
K992785 IBC FLOGUARD, MODEL 6050 International Biophysics Corp. MJJ Class II 2000-01-14
K992749 ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 Spacelabs Medical, Inc. MSX Class II 2000-01-14
K993531 PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX Datascope Corp. DSI Class II 2000-01-13
K993550 AVIVA SYSTEM, MODEL SL1010 American Telecare, Inc. DRG Class II 2000-01-13
K992053 AESCULAP VASCULAR INSTRUMENTS Aesculap, Inc. DXC Class II 2000-01-13
K994358 ATW MARKER WIRE STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 2000-01-13
K992454 VENAFLOW SYSTEM, MODEL 30A Aircast, Inc. JOW Class II 2000-01-13
K994208 AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 Medtronic Perfusion Systems DTM Class II 2000-01-13
K992584 PE 501 PC-ECG MONITOR Nhe Corp. MWJ Class II 2000-01-13
K993455 FLIPPER DETACHABLE EMBOLIZATION COIL Cook, Inc. KRD Class II 2000-01-11
K993460 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 Rossmax International , Ltd. DXN Class II 2000-01-11
K993426 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44 Rossmax International , Ltd. DXN Class II 2000-01-07
K993429 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 Rossmax International , Ltd. DXN Class II 2000-01-07
K992455 NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES Nihon Kohden America, Inc. DQA Class II 2000-01-07
K983866 BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP Belmont Instrument Corp. DSP Class II 2000-01-06
K993376 ENSTYLET MODELS EC0010, EC0020 Endocardial Solutions, Inc. DRB Class II 2000-01-05
K994252 INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE Boston Scientific Corp DYB Class II 2000-01-04
K993672 REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 Micro Therapeutics, Inc. KRA Class II 2000-01-04
K991647 TFX MEDICAL INTRODUCER KIT Tfx Medical Group DYB Class II 2000-01-04
K993542 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46 Rossmax International , Ltd. DXN Class II 1999-12-29
K993288 SULZER CARBOMEDICS CARDIOFIX PERICARDIUM Sulzer Carbomedics, Inc. DXZ Class II 1999-12-29
K993643 NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 Nexan Telemed , Ltd. MWJ Class II 1999-12-28
K991541 A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 A-Med Systems, Inc. DWF Class II 1999-12-28
K992092 STAT-SHELL DISPOSABLE SPO2 SENSOR Epic Medical Equipment Services, Inc. DQA Class II 1999-12-22
K992211 SPO2 WRAP SENSOR Epic Medical Equipment Services, Inc. DQA Class II 1999-12-22
K990173 PATHFINDER II ANGIOGRAPHIC CATHETER Maxxim Medical DQO Class II 1999-12-21
K994009 CG-2100 ECG TRANSMITTER Card Guard Scientific Survival , Ltd. DXH Class II 1999-12-21
K992121 EMBOLIZATION COIL SYSTEM Cook, Inc. KRD Class II 1999-12-20
K993888 A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS A&D Engineering, Inc. DXN Class II 1999-12-20
K993432 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 Rossmax International , Ltd. DXN Class II 1999-12-20
K993169 MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A Hewlett-Packard Co. DRG Class II 1999-12-20
K992635 INTERFACE MODULE IDDD Stoeckert Instrumente KRI Class I 1999-12-20
K993139 YP 45/15-BP; YP 53/15-BP; YP 60/15-BP Biotronik, Inc. DTB Class III 1999-12-17
K990058 QMS MAPPING SYSTEM,MODEL 2000 Cathdata, Inc. DQK Class II 1999-12-15
K992631 ACUNAV DIAGNOSTIC ULTRASOUND CATHETER Acuson Corp. DQO Class II 1999-12-15
K983250 INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR Magnetic Resonance Equipment Corp. DSK Class II 1999-12-12
K993062 CHEST DRAINAGE TUBING Olson Medical Sales, Inc. DWE Class II 1999-12-10
K993799 CG-7000DX ECG RECORDER/TRANSMITTER Card Guard Scientific Survival , Ltd. DXH Class II 1999-12-10
K991714 DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 Doctor'S Research Group, Inc. DQD Class II 1999-12-10
K993072 SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) Survivalink Corp. MKJ Class III 1999-12-10
K991878 LUMA-CATH STEERABLE EP CATHETERS Irvine Biomedical, Inc. DRF Class II 1999-12-10
K991756 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE Bio-Research Associates, Inc. DQD Class II 1999-12-10
K992368 LEMAITRE EMBOLECTOMY CATHETER Vascutech, Inc. DXE Class II 1999-12-09
K990503 SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS Sulzermedica DSY Class II 1999-12-09
K992595 HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH Hewlett-Packard GmbH MHX Class II 1999-12-08
K993774 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH Acist Medical Systems DXT Class II 1999-12-07
K990113 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 Maersk Medical A/S DRX Class II 1999-12-06
K990115 DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 Maersk Medical A/S DRX Class II 1999-12-06
K990112 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 Maersk Medical A/S DRX Class II 1999-12-06
K990110 DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 Maersk Medical A/S DRX Class II 1999-12-06
K990111 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 Maersk Medical A/S DRX Class II 1999-12-06
K984088 OPTISTAR MR INJECTOR SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business DXT Class II 1999-12-06
K981655 SPACELABS MEDICAL DISPOSABLE SP02 SENSOR Spacelabs Medical, Inc. DQA Class II 1999-12-03
K993729 MODIFICATION TO CARTO EP NAVIGATION SYSTEM Biosense Webster, Inc. DQK Class II 1999-12-03
K993001 COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED Cobe Cardiovascular, Inc. DTN Class II 1999-12-03
K990807 HL148 & HL168 Health & Life Co., Ltd. DXN Class II 1999-12-03
K992479 ENSITE 3000 SYSTEM Endocardial Solutions, Inc. DQK Class II 1999-12-02
K993890 DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 1999-12-01
K992977 HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A Hewlett-Packard Co. MKJ Class III 1999-12-01
K992948 MAC-LAB SYSTEM General Electric Medical Systems Information Techn DQK Class II 1999-11-29
K993728 MEDRAD ENVISION CT INJECTOR SYSTEM Medrad, Inc. DXT Class II 1999-11-26
K992929 DASH 3000 PATIENT MONITOR General Electric Medical Systems Information Techn MHX Class II 1999-11-26
K990727 SYNEFLASH & SYNEVIEW Ela Medical, Inc. DQK Class II 1999-11-26
K992965 CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 Cordis Webster, Inc. DRF Class II 1999-11-26
K991105 ECG ELECTRODE (VARIOUS) Conmedcorp DRX Class II 1999-11-26
K993618 DXP1000 HOLTER RECORDER Braemar Corp. MWJ Class II 1999-11-24
K993648 ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER Boston Scientific Corporation Northwest Technology MCW Class II 1999-11-24
K993637 N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS Nellcor Puritan Bennett, Inc. DQA Class II 1999-11-24
K993617 DIGITRAKPLUS HOLTER RECORDER Braemar Corp. MWJ Class II 1999-11-24
K990512 STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS Stoeckert Instrumente KRI Class I 1999-11-23
K992848 ALARMVIEW SYSTEM Data Critical Corp. MSX Class II 1999-11-19

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