meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
51
Latest Decision
2003-04-22

Clearances · page 91 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030556 STEELEX ELECTRODE SET Aesculap, Inc. LDF Class II 2003-04-22
K030203 LONG WELL LW-6DXX SERIES BODY FAT ANALYZER Long Well Electronics Corp. MNW Class II 2003-04-21
K030231 CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON Sorin Group Italia S.R.L. DWF Class II 2003-04-18
K021421 PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE Tz Medical, Inc. DRF Class II 2003-04-18
K030499 HL888HM Health & Life Co., Ltd. DXN Class II 2003-04-17
K030613 VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 Criticare Systems, Inc. MHX Class II 2003-04-17
K030498 HL888HA Health & Life Co., Ltd. DXN Class II 2003-04-11
K030696 RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) Medtronic Perfusion Systems DWF Class II 2003-04-11
K021154 GOLDWAY PATIENT MONITOR, MODEL # UT4000F Goldway Us, Inc. MWI Class II 2003-04-11
K030999 EPTFE VASCULAR PROSTHESIS; SEALPTFE Vascutek, Ltd. DSY Class II 2003-04-09
K030905 MEDAMICUS FLOWGUARD PEELABLE INTRODUCER Medamicus, Inc. DYB Class II 2003-04-09
K021802 STEREOTAXIS CATHETER ADVANCER SYSTEM Stereotaxis, Inc. DQY Class II 2003-04-08
K030656 ENVAN HEART RATE MONITOR Envan, LLC DRT Class II 2003-04-08
K030062 ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 Avantec Vascular Corp. LIT Class II 2003-04-03
K024300 MICROCAP PLUS/NPB-75 Oridion Medical 1987 , Ltd. DQA Class II 2003-04-03
K030723 IVS INTRODUCER SET, MODEL 1003 Integrated Vascular Systems, Inc. DYB Class II 2003-04-03
K023833 GISH ARTERIAL FILTER WITH GBS COATING Gish Biomedical, Inc. DTM Class II 2003-03-31
K030154 IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR Dideco S.P.A. KFM Class II 2003-03-31
K023381 VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING Gish Biomedical, Inc. DTZ Class II 2003-03-31
K030856 ER800 SERIES ECG EVENT RECORDER Braemar Corp. MWJ Class II 2003-03-28
K012677 REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. NLF Class II 2003-03-28
K030073 VERMED A10021 RESTING EKG TAB ELECTRODE Vermont Medical, Inc. DRX Class II 2003-03-28
K030825 MPM-NET Aerotel Medical Systems (1998) , Ltd. DXN Class II 2003-03-28
K030688 ECHELON MICRO CATHETER, MODEL 105-5092-150 Micro Therapeutics, Inc. KRA Class II 2003-03-28
K030201 MODIFICATION TO EXPORT ASPIRATION CATHETER Medtronic Vascular NFA Class II 2003-03-26
K024327 SETPOINT ENDOVASCULAR TEMPERATURE PROBE Radiant Medical DQY Class II 2003-03-25
K020271 LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 Levitronix, LLC KFM Class II 2003-03-25
K030615 INFINITY EXPLORER Siemens Medical Solutions USA, Inc. MSX Class II 2003-03-21
K023078 BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR Vsm Medtech , Ltd. DXN Class II 2003-03-21
K030114 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2003-03-21
K030575 MODIFICATION TO SOLAR 9500 INFORMATION MONITOR Ge Medical Systems Information Technologies MHX Class II 2003-03-21
K030657 SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 Siemens Medical Solutions MHX Class II 2003-03-21
K030731 M2376A DEVICELINK SYSTEM Philips Medical Systems, Inc. MWI Class II 2003-03-21
K022947 ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH Terumo Cardiovascular Systems Corp. DTQ Class II 2003-03-20
K030005 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES Vanguard Medical Concepts, Inc. DSA Class II 2003-03-18
K024235 DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER Dolphin Medical, Inc. DQA Class II 2003-03-17
K030077 GISH TUBING AND CONNECTORS WITH GBS COATING Gish Biomedical, Inc. DTL Class II 2003-03-14
K030532 CPCA2000 COUNTERPULSATION SYSTEM Cpca2000, Inc. DRN Class II 2003-03-14
K030038 PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR Philips Medical Systems, Inc. MHX Class II 2003-03-12
K022004 CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 Biosensors International-USA DQO Class II 2003-03-12
K024087 REPROCESSED COMPRESSION SLEEVES Alliance Medical Corp. JOW Class II 2003-03-11
K030476 MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 Concentric Medical, Inc. DQY Class II 2003-03-11
K024077 DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR Zewa, Inc. DXN Class II 2003-03-10
K024074 REPROCESSED COMPRESSION SLEEVES Alliance Medical Corp. JOW Class II 2003-03-07
K012706 IM2001 PULSE OXIMETER Imagyn Medical Technologies, Inc. DQA Class II 2003-03-07
K024122 NAUTICA MICRO CATHETER, MODEL 105-5094-153 Micro Therapeutics, Inc. KRA Class II 2003-03-07
K030462 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 Cobe Cardiovascular, Inc. KFM Class II 2003-03-06
K024065 SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING Gish Biomedical, Inc. DTN Class II 2003-03-05
K030449 MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR Terumo Corp. DTN Class II 2003-03-05
K030509 SKINTACT ECG TAB ELECTRODE Leonhard Lang GmbH DRX Class II 2003-03-04
K030105 ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A Nihon Kohden America, Inc. MHX Class II 2003-03-04
K030524 CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN Cd Leycom BV OBJ Class II 2003-03-03
K030264 QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 Jostra AG DTZ Class II 2003-02-26
K030431 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR Ge Medical Systems Information Technologies MHX Class II 2003-02-26
K023637 TYTAN ELECTRONIC STETHOSCOPES (MODEL #600) Tytan Medical Corp. DQD Class II 2003-02-26
K030141 MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 Cardiovention, Inc. DTQ Class II 2003-02-26
K023942 CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311 Yamato Corp. MNW Class II 2003-02-24
K023914 COAXIA FLOCONTROL CATHETER Coaxia, Inc. MJN Class II 2003-02-21
K023351 MAGIC INFUSION CATHETER Advanced Interventional Technologies, LLC KRA Class II 2003-02-20
K030260 GELBFISH FLEX VASCULAR DILATOR Vascumetrix, LLC DRE Class II 2003-02-20
K023463 CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT Cryo Vascular Systems, Inc. DQY Class II 2003-02-19
K023238 MCPULSE Meridian Co., Ltd. JOM Class II 2003-02-19
K022340 TRAVELAIR PORTABLE COMPRESSION SYSTEM Dynamic Air, Inc. JOW Class II 2003-02-19
K023854 SAMARITAN AED, MODEL SAM-01 Heartsine Technologies, Inc. MKJ Class III 2003-02-14
K022071 EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 Embol-X, Inc. DTM Class II 2003-02-14
K024071 GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM Guidant Corporation, Cardiac Surgery NHW Class II 2003-02-14
K022813 STEERABLE GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2003-02-14
K021469 MINOLTA PULSOX-2 Konica Minolta Sensing, Inc. DQA Class II 2003-02-12
K023707 A16 BLOOD FLOW MEASUREMENT SYSTEM D. E. Hokanson, Inc. JOM Class II 2003-02-12
K024005 WELCH ALLYN VITAL SIGN MONITOR WITH MP506 Welch Allyn, Inc. DXN Class II 2003-02-12
K030313 SIEMENS INFINITY SC 6002XL MODIFICATIONS Siemens Medical Solutions USA, Inc. MHX Class II 2003-02-11
K020534 MEDSTAR SYSTEM, MODELS 533-300 Cybernet Medical DXH Class II 2003-02-11
K023800 VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 Aircast, Inc. JOW Class II 2003-02-10
K024128 ALLON 2001 VERSION 5 Mtre Advanced Technology , Ltd. DWJ Class II 2003-02-10
K021654 REPROCESSED COMPRESSION SLEEVE Alliance Medical, Inc. JOW Class II 2003-02-05
K024118 ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 Micro Therapeutics, Inc. KRA Class II 2003-02-03
K022201 RADIUS MICRO SNARE Radius Medical Technologies, Inc. MMX Class II 2003-02-03
K022596 BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) Clover Hi-Tech, Inc. DQK Class II 2003-01-31
K024053 PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB Oscor, Inc. DTB Class III 2003-01-31
K023701 ANGIONEW-IV Living Data Technologies Corporation DRN Class II 2003-01-30
K021340 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE External Counterpulsation Lab DRN Class II 2003-01-30
K022929 PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 Cardiac Science, Inc. MKJ Class III 2003-01-27
K022360 ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. Biotronik, Inc. DTA Class II 2003-01-27
K020892 ACIST GENTOO CONTRAST INJECTION SYSTEM Acist Medical Systems DXT Class II 2003-01-27
K022366 CELSIUS CONTROL SYSTEM Innercool Therapies NCX Class II 2003-01-27
K030019 MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE Guidant Corp. DQX Class II 2003-01-24
K021547 FLOWLINE BIOPORE EPTFE VASCULAR GRAFT Jotec GmbH DSY Class II 2003-01-24
K024021 NITREX NITINOL GUIDEWIRE Ev3 Corporation DQX Class II 2003-01-24
K023878 GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM Medtronic Vascular NFA Class II 2003-01-24
K023934 RAPID THERMAL EXCHANGE SYSTEM Avacore Technologies, Inc. DWJ Class II 2003-01-23
K023114 LUMEND FRONTRUNNER CTO CATHETER Lumend, Inc. PDU Class II 2003-01-23
K022170 INNER-LOCK LOCKING INTRODUCER SHEATHS Rex Medical DYB Class II 2003-01-21
K023689 CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM Card Guard Scientific Survival , Ltd. DXH Class II 2003-01-17
K023745 SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G Sechrist Industries, Inc. DTX Class II 2003-01-17
K023682 ENCLOSE ANASTOMOSIS ASSIST DEVICE Novare Surgical Systems, Inc. DXC Class II 2003-01-16
K023356 KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR Card Guard Scientific Survival , Ltd. DXQ Class II 2003-01-16
K024247 SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL Leonhard Lang GmbH DRX Class II 2003-01-16
K023920 SKINTACT Leonhard Lang GmbH DRX Class II 2003-01-16
K024264 SKINTACT Leonhard Lang Co. DRX Class II 2003-01-16
K021555 STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM Stereotaxis, Inc. DXX Class II 2003-01-15

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