meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
2005-10-21

Clearances · page 81 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K052161 POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) Cardiac Science, Inc. MKJ Class III 2005-10-21
K052717 D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER Dideco S.R.L. DTM Class II 2005-10-20
K052707 M3046B COMPACT PORTABLE PATIENT MONITORS Philips Medical Systems MHX Class II 2005-10-20
K052514 CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 Spectranetics Corp. PDU Class II 2005-10-19
K052240 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 Cardionet, Inc. QYX Class II 2005-10-19
K052046 BLOOD PRESSURE METER, MODEL CH-432 Citizen Watch Co., Ltd. DXN Class II 2005-10-19
K052633 DUAL SHOT - CONTRAST DELIVERY SYSTEM Nemoto Kyorindo Co., Ltd. DXT Class II 2005-10-17
K052443 ICY CATHETER, MODEL IC-3893A Alsius Corp. NCX Class II 2005-10-17
K051805 KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE Tyco Healthcare/Kendall JOW Class II 2005-10-13
K052755 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT GE Healthcare DQA Class II 2005-10-13
K051912 COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B Alsius Corp. NCX Class II 2005-10-11
K051544 VITALCAREGIVING SYSTEM Advanced Monitoring Caregiving, Inc. DXH Class II 2005-10-07
K052436 PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 Denver Biomedical, Inc. DWM Class II 2005-10-06
K051534 CARDIOLINE AR 600, AR 1200, AR 2100 Et Medical Devices Spa DPS Class II 2005-10-05
K051632 PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A Philips Medical Systems MKJ Class III 2005-10-05
K050097 TECHNO-SCOPE VISUAL STETHOSCOPE Techtrade, LLC DQD Class II 2005-09-30
K042998 REFSTAR RMT EXTERNAL REFERENCE PATCH Biosense Webster, Inc. DRF Class II 2005-09-29
K042681 CARTO RMT EP NAVIGATION SYSTEM Biosense Webster, Inc. DQK Class II 2005-09-29
K051332 ADVANTA T-GRAFT Atrium Medical Corp. DSY Class II 2005-09-29
K052083 NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER Biosense Webster, Inc. DRF Class II 2005-09-29
K052232 VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER Vascular Solutions, Inc. QEZ Class II 2005-09-28
K051772 ASAHI TORNUS SUPPORT CATHETER Asahi Intecc Co., Ltd. DQY Class II 2005-09-26
K051730 MATRIX HOLTER SYSTEM, MODEL M12 Global Instrumentation, LLC MLO Class II 2005-09-26
K052372 MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C Medtronic Perfusion Systems DWF Class II 2005-09-22
K052282 VENAFLO II VASCULAR GRAFT Bard Peripheral Vascular, Inc. DSY Class II 2005-09-20
K051997 CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR Terumo Cardiovascular Systems Corp. DTZ Class II 2005-09-15
K051366 PICONIBP OEM MODULE Philips Medizin Systeme Boeblingen GmbH DXN Class II 2005-09-14
K052454 THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM Abbott Vascular Devices NTE Class II 2005-09-14
K051565 PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA Proton Healthcare , Ltd. DXN Class II 2005-09-12
K052302 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION Boston Scientific Corp MAL Class II 2005-09-12
K052205 CAPIOX AF125X ARTERIAL FILTER Terumo Cardiovascular Systems Corp. DTM Class II 2005-09-12
K051655 ANGIODYNAMICS, INC., MICRO ACCESS KITS AngioDynamics, Inc. DQR Class II 2005-09-12
K051904 ALL PURPOSE CUFF, MODEL 222APC Suntech Medical, Inc. DXQ Class II 2005-09-09
K052154 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC Omron Healthcare, Inc. DXN Class II 2005-09-08
K052153 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL Omron Healthcare, Inc. DXN Class II 2005-09-08
K051134 HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A Philips Medical Systems MKJ Class III 2005-09-08
K051209 LEVITRONIX CENTRIMAG BACK-UP CONSOLE Levitronix, LLC KFM Class II 2005-09-08
K052185 DESTINATION CAROTID GUIDING SHEATH Terumo Medical Corp. DYB Class II 2005-09-06
K052209 VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 Vascular Control Systems, Inc. DPW Class II 2005-09-06
K050863 IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific Corp DQO Class II 2005-09-02
K052149 EDWARDS PERIPHERAL DILATION CATHETER Edwards Lifesciences, LLC DQY Class II 2005-09-02
K050629 ANGIOSCULPT SCORING BALLOON CATHETER Angioscore, Inc. PNO Class II 2005-09-02
K042782 SEER MC Ge Medical Systems Information Technologies MLO Class II 2005-09-02
K050443 ACCU-LEAD Kentec Medical, Inc. DRX Class II 2005-09-02
K052296 CLIRPATH TURBO EXCIMER LASER CATHETERS Spectranetics Corp. PDU Class II 2005-09-02
K051515 MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 Acumen Medical, Inc. DYB Class II 2005-09-01
K051838 MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 Concentric Medical, Inc. DQY Class II 2005-09-01
K051405 REGENSIS PERICARDIAL PATCH Cormatrix Cardiovascular, Inc. DXZ Class II 2005-08-31
K050558 MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F C.R. Bard, Inc. DTK Class II 2005-08-29
K052049 PHILIPS 12-LEAD ALGORITHM Philips Medical Systems DPS Class II 2005-08-26
K050399 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 Invivo Research, Inc. MWI Class II 2005-08-26
K052022 ASAHI PTCA GUIDE WIRE FIELDER Asahi Intecc Co., Ltd. DQX Class II 2005-08-25
K052036 ATB ADVANCE PTA DILATATION CATHETER Cook, Inc. DQY Class II 2005-08-25
K050896 H12+ HOLTER RECORDER Mortara Instrument, Inc. DSH Class II 2005-08-24
K052236 BARD ATLAS PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. DQY Class II 2005-08-23
K051862 PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. Ya Horng Electronic Co., Ltd. DXN Class II 2005-08-23
K051960 CARDIONAVIGATOR + Del Mar Reynolds Medical, Ltd. DXH Class II 2005-08-19
K051863 AMLUCK, YA HORNG Ya Horng Electronic Co., Ltd. DXN Class II 2005-08-19
K052166 MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM Guidant Corporation NTE Class II 2005-08-18
K051337 EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 Volcano Corporation OBJ Class II 2005-08-18
K043465 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 Spectranetics Corp. PDU Class II 2005-08-18
K052038 PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM Boston Scientific Corporation LIT Class II 2005-08-16
K052165 RX ACCUNET EMBOLIC PROTECTION SYSTEM Guidant Corporation NTE Class II 2005-08-16
K052071 LYSUS INFUSION SYSTEM Ekos Corp. QEY Class II 2005-08-16
K051703 CLEVER TD-3018A BLOOD PRESSURE MONITOR Taidoc Technology Corporation DXN Class II 2005-08-12
K051038 506 PATIENT MONITOR Ciriticare Systems, Inc. DRT Class II 2005-08-12
K051897 TRIO MONITOR Datascope Corp. MWI Class II 2005-08-12
K051606 GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING Gish Biomedical, Inc. DTN Class II 2005-08-12
K051352 OXIMAX NPB-40 HANDHELD PULSE OXIMETER Nellcor Puritan Bennett, Inc. DQA Class II 2005-08-11
K051368 BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM Schiller AG DXN Class II 2005-08-09
K051917 DIVER C.E. CATHETER Invatec Innovative Technologies, S.R.L. QEZ Class II 2005-08-08
K051193 VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER Vascular Solutions, Inc. QEZ Class II 2005-08-08
K051042 METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 Angiometrx, Inc. LIT Class II 2005-08-05
K051846 7F SHERPA NX GUIDE CATHETER Medtronic Vascular DQY Class II 2005-08-05
K051916 POLAR CATH PERIPHERAL DILATATION SYSTEM Cryo Vascular Systems, Inc. LIT Class II 2005-08-05
K051539 TRICOT BLOOD PRESSURE CUFF Ya Horng Electronic Co., Ltd. DXQ Class II 2005-08-05
K051601 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. DYB Class II 2005-08-04
K051468 INNER-LOCK INTRODUCER SHEATH Rex Medical DYB Class II 2005-08-04
K051375 VITAL SIGNS MONITOR Mediana Co., Ltd. DXN Class II 2005-07-28
K050857 BIB PTA BALLOON CATHETER NuMED, Inc. NVM Class II 2005-07-28
K051343 MINI GHOST PTA CATHETER, MODEL 507 NuMED, Inc. DQY Class II 2005-07-28
K051790 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 3M Company DQD Class II 2005-07-25
K051628 INFINITY MONITORS WITH SCIO MODIFICATIONS Draeger Medical Systems, Inc. MHX Class II 2005-07-20
K050951 MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 Cibernet Systems Corp. DXH Class II 2005-07-19
K051026 MARS HOLTER ANALYSIS WORKSTATION Ge Medical Systems Information Technologies DQK Class II 2005-07-19
K051634 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION GE Healthcare MSX Class II 2005-07-19
K051062 VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO Flowcardia, Inc. DQX Class II 2005-07-15
K051439 LNOP BLUE OXIMETRY SENSOR Masimo Corporation DQA Class II 2005-07-15
K050620 READMYHEART, MODEL RMH3.0 Dailycare Biomedical, Inc. DPS Class II 2005-07-14
K051679 ILAB ULTRASOUND IMAGING SYSTEM Boston Scientific Corp OBJ Class II 2005-07-14
K051686 CARDIOMEM CM 3000-12 Getemed Medizin- Und Informationstechnik AG MWJ Class II 2005-07-14
K050395 IMPEDIMED - BODY COMPOSITION ANALYSIS Impedimed Pty , Ltd. MNW Class II 2005-07-13
K051212 MODIFICATION TO LNCS OXIMETRY SENSORS Masimo Corporation DQA Class II 2005-07-12
K051518 UNITY NETWORK ID Ge Medical Systems Information Technologies MWI Class II 2005-07-08
K050018 TESLAOXYSAT, MODEL EFOXYSATE Mammendorfer Institute For Physics & Medicine GmbH DQA Class II 2005-07-01
K051106 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH DXN Class II 2005-07-01
K050940 PMP4 MEDICAL WEB CENTER Card Guard Scientific Survival , Ltd. DXH Class II 2005-07-01
K050858 ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM Heartlab, Inc. DPS Class II 2005-06-29
K051608 STAR 50 MONITORING SYSTEM Larsen & Toubro Limited MWI Class II 2005-06-29
K042891 DATEX-OHMEDA OXY-AFR SENSOR Datex-Ohmeda NLF Class II 2005-06-29

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