Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 47
- Latest Decision
- 2000-05-17
Clearances · page 103 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K000563 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | MHX | Class II | 2000-05-17 |
| K001348 | ST/AR ST AND ARRHYTHMIA SOFTWARE | Agilent Technologies, Inc. | MHX | Class II | 2000-05-17 |
| K000690 | 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE | Minnesota Mining and Mfg. Co. | DRX | Class II | 2000-05-17 |
| K001308 | MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW | Agilent Technologies | DQA | Class II | 2000-05-17 |
| K000775 | HEART 2005 | Aerotel Medical Systems (1998) , Ltd. | DXH | Class II | 2000-05-17 |
| K000303 | HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB | Healthcare Service and Supply | JOW | Class II | 2000-05-16 |
| K994334 | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX | Daig Corp. | DYB | Class II | 2000-05-15 |
| K001198 | DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET | Datascope Corp. | DQX | Class II | 2000-05-12 |
| K991886 | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR | Pulsion Medical Systems, Inc. | KRB | Class II | 2000-05-11 |
| K001139 | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M | Biosense Webster, Inc. | DYB | Class II | 2000-05-10 |
| K000190 | MODIFICATION TO CARTO EP NAVIGATION SYSTEM | Biosense Webster, Inc. | DQK | Class II | 2000-05-05 |
| K001100 | BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH | Cardiodynamics International Corp. | DSB | Class II | 2000-05-05 |
| K991293 | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR | Fischer Medical Technologies, Inc. | JOQ | Class II | 2000-05-05 |
| K000248 | CARTO EP NAVIGATION SYSTEM | Biosense Webster, Inc. | DQK | Class II | 2000-05-05 |
| K994243 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP | Heartport, Inc. | DWF | Class II | 2000-05-05 |
| K992592 | A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 | A-Med Systems, Inc. | KFM | Class II | 2000-05-04 |
| K993816 | BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD | Baxter Edwards | MCW | Class II | 2000-05-04 |
| K000332 | NOGA CARDIAC NAVIGATION SYSTEM | Biosense Webster, Inc. | DQK | Class II | 2000-05-04 |
| K000579 | TEMPO AQUA ANGIOGRAPHIC CATHETER | Cordis Corp. | DQO | Class II | 2000-05-03 |
| K001057 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR | Agilent Technologies, Inc. | DSI | Class II | 2000-05-03 |
| K001085 | MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 | Nonin Medical, Inc. | DQA | Class II | 2000-05-01 |
| K001020 | 8100 VITAL SIGNS MONITOR | Criticare Systems, Inc. | MWI | Class II | 2000-04-28 |
| K993564 | POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 | Possis Medical, Inc. | MCW | Class II | 2000-04-28 |
| K994372 | MODEL 120 | Palco Labs, Inc. | DQA | Class II | 2000-04-28 |
| K001136 | CORDIS INTRODUCER GUIDE | Cordis Corp. | DQY | Class II | 2000-04-28 |
| K001138 | AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 | Medtronic Vascular | DTM | Class II | 2000-04-27 |
| K994171 | MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE | Medtronic Cardiac Surgical Products | DWF | Class II | 2000-04-27 |
| K001021 | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 | Dideco S.P.A. | DTZ | Class II | 2000-04-25 |
| K000255 | COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR | Cobe Cardiovascular, Inc. | DTZ | Class II | 2000-04-25 |
| K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS | Boston Scientific Scimed, Inc. | DQO | Class II | 2000-04-21 |
| K001025 | LIFECARD CF COMPACT RECORDER | Reynolds Medical , Ltd. | DSH | Class II | 2000-04-19 |
| K993677 | MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT | Medtronic Vascular | DWF | Class II | 2000-04-17 |
| K000366 | FIXATION STYLETS, MODELS 335-287 AND 335-288 | Accufix Research Institute | DRB | Class II | 2000-04-14 |
| K001033 | AGILITY STEERABLE GUIDEWIRE | Cordis Neurovascular, Inc. | DQX | Class II | 2000-04-14 |
| K000126 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA | Masimo Corp. | DQA | Class II | 2000-04-14 |
| K000147 | CTC DVT-1 CALF GARMENT, MODEL DVT-1 | Compression Therapy Concepts, Inc. | JOW | Class II | 2000-04-13 |
| K992664 | TFX MEDICAL STYLET CATHETER | Tfx Medical Group | DRB | Class II | 2000-04-13 |
| K000824 | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX | Medamicus, Inc. | DYB | Class II | 2000-04-13 |
| K994240 | EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 | Biotronik, Inc. | DTB | Class III | 2000-04-13 |
| K000168 | CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) | Datex-Ohmeda | MHX | Class II | 2000-04-13 |
| K992942 | LEMAITRE OCCLUSION CATHETER | Vascutech, Inc. | MJN | Class II | 2000-04-13 |
| K000570 | BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA | Boston Scientific Corp | LIT | Class II | 2000-04-13 |
| K993608 | DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) | Datex-Ohmeda, Inc. | MHX | Class II | 2000-04-13 |
| K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | Axelgaard Mfg. Co., Ltd. | DRX | Class II | 2000-04-13 |
| K000098 | SOFTLINE SPRING CLIP | Novare Surgical Systems, Inc. | DXC | Class II | 2000-04-12 |
| K972610 | POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C | Possis Medical, Inc. | QEZ | Class II | 2000-04-11 |
| K991458 | MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254 | Matsushita Electric Corp. of America | DXN | Class II | 2000-04-10 |
| K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Ela Medical, Inc. | DTB | Class III | 2000-04-10 |
| K000854 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER | Agilent Technologies, Inc. | MHX | Class II | 2000-04-10 |
| K000794 | MODIFICATION TO MARSPO2, MODEL 2001 | Novametrix Medical Systems, Inc. | DQA | Class II | 2000-04-10 |
| K993305 | TRANSLUMINAL BALLOON DILATATION CATHETER | Boston Scientific Corp | LIT | Class II | 2000-04-10 |
| K000177 | RENEGADE HI-FLO MICROCATHETER | Boston Scientific Corp | KRA | Class II | 2000-04-07 |
| K000746 | FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX | Fukuda Denshi USA, Inc. | DSI | Class II | 2000-04-07 |
| K993414 | PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 | Prucka Engineering, Inc. | DPS | Class II | 2000-04-07 |
| K000822 | AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR | Agilent Technologies, GmbH | DSI | Class II | 2000-04-06 |
| K000763 | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 | Biotronik, GmbH & Co. | DTB | Class III | 2000-04-06 |
| K000753 | CORDIS 13F CATHETER SHEATH INTRODUCER | Cordis Corp. | DRF | Class II | 2000-04-06 |
| K991060 | ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 | Zcv ,Inc. | DRF | Class II | 2000-04-06 |
| K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Ela Medical, Inc. | DTB | Class III | 2000-04-04 |
| K000715 | ENVOY AND VISTA BRITE TIP | Cordis Corp. | DQY | Class II | 2000-03-31 |
| K993512 | DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER | Datex-Ohmeda, Inc. | DQA | Class II | 2000-03-31 |
| K000659 | MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT | Merit Medical Systems, Inc. | DQO | Class II | 2000-03-29 |
| K000677 | ZUMA GUIDE CATHETERS | Medtronic Vascular | DQY | Class II | 2000-03-29 |
| K992215 | MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED | Envitec-Wismar GmbH | DQA | Class II | 2000-03-29 |
| K994423 | AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 | Vsm Medtech , Ltd. | DXN | Class II | 2000-03-28 |
| K993060 | GAS FILTER | Olson Medical Sales, Inc. | JOD | Class II | 2000-03-28 |
| K000660 | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 | Medical Data Electronics | DRO | Class II | 2000-03-28 |
| K994430 | IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM | General Electric Medical Systems Information Techn | MSX | Class II | 2000-03-28 |
| K981093 | WESCO BLANKET | Wesco, Inc. | DWJ | Class II | 2000-03-28 |
| K000013 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 | Acist Medical Systems | DXT | Class II | 2000-03-28 |
| K994389 | COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED | Cobe Cardiovascular, Inc. | DTN | Class II | 2000-03-27 |
| K000598 | 5F GUIDING CATHETER | Guidant Corp. | DQY | Class II | 2000-03-24 |
| K993191 | TFX MEDICAL INTRODUCER ASSEMBLY | Tfx Medical, Inc. | DYB | Class II | 2000-03-24 |
| K994011 | EP MEDSYSTEMS, EP-WORKMATE | Ep Medsystems, Inc. | DQK | Class II | 2000-03-23 |
| K983826 | 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM | Unimachs Corp. | DXT | Class II | 2000-03-23 |
| K993292 | BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER | Boston Scientific, Target | MJN | Class II | 2000-03-23 |
| K993826 | NARKOMED 6000 | Draeger Medical, Inc. | MLC | Class II | 2000-03-23 |
| K993757 | SOLAR 7/8000 | General Electric Medical Systems Information Techn | DSI | Class II | 2000-03-23 |
| K992174 | PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP | Pilling Weck Surgical | DXC | Class II | 2000-03-23 |
| K992703 | CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 | Premier Heart, LLC | DQK | Class II | 2000-03-21 |
| K000635 | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM | Agilent Technologies, Inc. | MWI | Class II | 2000-03-20 |
| K993938 | THE HOMMED SENTRY, MODEL 1 SENTRY | Hommed, LLC | DXN | Class II | 2000-03-15 |
| K990975 | IN-LINE HEMOSTASIS VALVE | Merit Medical Systems, Inc. | DYB | Class II | 2000-03-15 |
| K994242 | BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT | Bodystat , Ltd. | MNW | Class II | 2000-03-15 |
| K000675 | MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 | Jawon Medical Co., Ltd. | DXN | Class II | 2000-03-14 |
| K994157 | DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 | Datascope Corp. | DSP | Class II | 2000-03-13 |
| K992933 | LEMAITRE IRRIGATION CATHETER | Vascutech, Inc. | DXE | Class II | 2000-03-08 |
| K992912 | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH | Cardiac Pathways Corp. | DRF | Class II | 2000-03-08 |
| K992386 | ALLON 2000 | Mtre Advanced Technology , Ltd. | DWJ | Class II | 2000-03-07 |
| K992908 | Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) | Quinton, Inc. | DSI | Class II | 2000-03-06 |
| K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING | Terumo Corp. | DWE | Class II | 2000-03-01 |
| K993694 | MIKRO-TIP ANGIOGRAPHIC CATHETER | Millar Instruments, Inc. | DQO | Class II | 2000-03-01 |
| K991684 | CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 | Thermogear, Inc. | DWJ | Class II | 2000-03-01 |
| K992934 | LEMAITRE VENOUS THROMBECTOMY CATHETER | Vascutech, Inc. | DXE | Class II | 2000-03-01 |
| K000276 | MPT 24 AND VITAL VIEW 24 | Criticare Systems, Inc. | DRG | Class II | 2000-03-01 |
| K000504 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | DYF | Class II | 2000-03-01 |
| K000011 | MODIFIED HYDROPHILIC COATED GUIDEWIRE | Lake Region Mfg., Inc. | DQX | Class II | 2000-03-01 |
| K992524 | PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES | Advantage Medical Electronics, Inc. | DSA | Class II | 2000-03-01 |
| K000499 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | DSY | Class II | 2000-03-01 |
| K000409 | MODIFICATION TO T-REX BIOPSY FORCEPS | Boston Scientific Corp | DWZ | Class II | 2000-02-28 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.