meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
2002-07-11

Clearances · page 94 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K021243 ILT TORQUER, MODEL 114TR1 Intra Luminal Therapeutics, Inc. DQX Class II 2002-07-11
K021899 CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 Concentric Medical, Inc. DQY Class II 2002-07-10
K013434 VP-2000/1000 Colin Corp. DXN Class II 2002-07-09
K020456 EASI 12 LEAD ALGORITHM Philips Medical Systems DRW Class II 2002-07-09
K021473 BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM Augustine Medical, Inc. DWJ Class II 2002-07-09
K021094 INTROCAN SAFETY IV CATHETER B.Braun Medical, Inc. DYB Class II 2002-07-03
K012609 CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 Clearmedical, Inc. NLF Class II 2002-07-03
K021366 MAC-LAB/CARDIOLAB EP/COMBOLAB General Electric Medical Systems Information Techn DQK Class II 2002-07-03
K021958 TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H Bacchus Vascular, Inc. QEY Class II 2002-07-03
K012622 CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 Clearmedical, Inc. NLF Class II 2002-07-03
K021453 HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A Philips Medical Systems MKJ Class III 2002-07-03
K012600 CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L Clearmedical, Inc. NLF Class II 2002-07-03
K021830 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM Cobe Cardiovascular, Inc. DTR Class II 2002-07-02
K013205 MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 Millar Instruments, Inc. DRQ Class II 2002-07-02
K014255 DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 Ge Medical Systems Information Technologies MWI Class II 2002-07-02
K020382 BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA Medicotest A/S DRX Class II 2002-06-28
K020211 BODY FORCE, MODEL BT 6000 Composites Solutions, Inc. JOW Class II 2002-06-28
K021097 QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 Spacelabs Medical, Inc. DSI Class II 2002-06-28
K021305 MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER Microlife Corp. DXN Class II 2002-06-28
K021756 WELCH ALLYN ABPM 6100 Welch Allyn, Inc. DXN Class II 2002-06-27
K021373 H12+HOLTER RECORDER Mortara Instrument, Inc. MWJ Class II 2002-06-27
K021168 JUMP START, MODEL 970300 Medical Research Laboratories, Inc. MKJ Class III 2002-06-26
K014009 TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE Tanita Corp. of America MNW Class II 2002-06-24
K021912 M2376 DEVICELINK SYSTEM Philips Medical Systems, Inc. MWI Class II 2002-06-24
K013593 CARDEON AEGIS CATHETER Cardeon Corp. DWF Class II 2002-06-24
K021721 EQUALIZER BALLOON CATHETER Boston Scientific Corp DQY Class II 2002-06-20
K021089 OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR Nellcor Puritan Bennett, Inc. DQA Class II 2002-06-19
K013896 SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA Defibtech, LLC MKJ Class III 2002-06-19
K021066 MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM Micro Therapeutics, Inc. MJN Class II 2002-06-18
K021252 BLOOD-PRESSURE METER Idt Technology Limited DXN Class II 2002-06-17
K020896 OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE Osypka Medical, Inc. DTE Class II 2002-06-14
K020857 EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER Vasomedical, Inc. DRN Class II 2002-06-14
K021441 RADIUS SNARE Radius Medical Technologies, Inc. MMX Class II 2002-06-14
K013297 AIRCAST, MODEL #3011 Millenium Reprocessing Services, Inc. JOW Class II 2002-06-14
K013022 SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS Sulzer Carbomedics, Inc. DSY Class II 2002-06-13
K021593 MODIFICATION TO ENVOY AND VISTA BRITE TIP Cordis Corp. DQY Class II 2002-06-13
K020834 BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I Becton Dickinson Infusion Therapy Systems, Inc. DYB Class II 2002-06-12
K012512 SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM Radiant Medical NCX Class II 2002-06-11
K021004 VALVED PEELABLE INTRODUCER Medamicus, Inc. DYB Class II 2002-06-06
K021462 ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 Arrow Intl., Inc. DSP Class II 2002-06-06
K013032 PHYSIOLOG, SERIES 95000 Camtronics, Ltd. DQK Class II 2002-06-04
K020821 SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 Biotronik, Inc. DQX Class II 2002-06-03
K020739 BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR Bci, Inc. DQA Class II 2002-06-03
K021129 CHARE CARIOVASCULAR PATCH Chase Medical, Inc. DXZ Class II 2002-06-03
K021606 EN-SNARE ENDOVASCULAR SNARE AND CATHETER Medical Device Technologies, Inc. MMX Class II 2002-05-31
K021587 ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A Medtronic Vascular DQY Class II 2002-05-30
K021589 ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 Medtronic Vascular DQY Class II 2002-05-30
K013615 MICRO-INDUCTION 1000 SYSTEM Harbinger Medical, Inc. DPS Class II 2002-05-29
K020743 PADPRO, MODEL 2502 Padpro, LLC MKJ Class III 2002-05-28
K011461 ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR Access Cardiosystems, Inc. LDD Class II 2002-05-28
K020661 UNITY IS PATIENT VIEWER General Electric Medical Systems Information Techn MSX Class II 2002-05-24
K020701 SYNCRUS INTERNAL CARDIOVERSION SYSTEM Guidant Corporation, Cardiac Surgery NHW Class II 2002-05-24
K020587 PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 Pulsion Medical Systems AG KRB Class II 2002-05-23
K021591 PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS Cordis Neurovascular, Inc. KRA Class II 2002-05-22
K021447 TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM Aerotel Medical Systems (1998) , Ltd. DXN Class II 2002-05-22
K021323 MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM Intra Luminal Therapeutics, Inc. DQX Class II 2002-05-22
K021225 ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I Rossmax International , Ltd. DXN Class II 2002-05-22
K021435 DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N Ge Medical Systems Information Technologies MWI Class II 2002-05-22
K020584 N2000 BASE STATION; N2001 NURSE STATION Neptec Design Group, Ltd. DXN Class II 2002-05-22
K020563 MEDAMICUS AXIA RSN Medamicus, Inc. DYB Class II 2002-05-21
K021219 SMARTWIRE/SMARTMAP PRESSURE SYSTEM Jomed, Inc. DQX Class II 2002-05-17
K021256 Z3 GUIDE CATHETER Medtronic Vascular DQY Class II 2002-05-17
K021232 CONSTELLATION CATHETERS, MODEL 8031M Boston Scientific Corp MTD Class II 2002-05-16
K021422 PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02 Philips Medical Systems MHX Class II 2002-05-15
K021228 HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE Guidant Corp. DQX Class II 2002-05-15
K012658 REPROCESSED COMPRESSION LIMB SLEEVES Surgical Instruments Service and Savings, Inc. JOW Class II 2002-05-14
K021246 SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 Sensidyne, Inc. DQA Class II 2002-05-13
K021090 OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER Nellcor Puritan Bennett, Inc. DQA Class II 2002-05-08
K021300 MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B Philips Medical Systems DSI Class II 2002-05-08
K021171 Q-STRESS ECHO BED Medical Positioning, Inc. DPS Class II 2002-05-08
K012979 COMPRESSIBLE LIMB SLEEVE Medical Device Services, Inc. JOW Class II 2002-05-08
K012712 NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 Norav Medical , Ltd. MLO Class II 2002-05-08
K020203 PADPRO MODEL #2516 Padpro, LLC MKJ Class III 2002-05-08
K020634 MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER Atrium Medical Corp. DXE Class II 2002-05-08
K013376 QFLOW 500 PERFUSION MONITORING SYSTEM Hemedex Incorporated DPW Class II 2002-05-08
K021287 TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT Medtronic Perfusion Systems DTN Class II 2002-05-07
K021251 ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. Philips Medical Systems DSI Class II 2002-05-07
K021325 MODIFICATION OF APEXPRO TELEMETRY SYSTEM General Electric Medical Systems Information Techn MHX Class II 2002-05-07
K021347 MODIFICATION TO M2376A DEVICELINK SYSTEM Philips Medical Systems MWI Class II 2002-05-07
K020365 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE 3t Medical Systems, LLC KRI Class I 2002-05-03
K011727 TRANSSEPTAL NEEDLE/TROCAR Thomas Medical Products, Inc. DRC Class II 2002-05-02
K021285 HI-TORQUE EXTRA S'PORT GUIDEWIRE Guidant Corp. DQX Class II 2002-05-02
K021283 GUIDANT BALLOON CATHETER, SEVERAL MODELS Guidant Corp. DQO Class II 2002-05-02
K021282 LV-1 HEMOSTASIS VALVE, MODEL #6789 Guidant Corp. DTL Class II 2002-05-02
K021284 EASYTRAK GUIDING CATHETER Guidant Corp. DQY Class II 2002-05-02
K013484 TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH Stereotaxis, Inc. DRF Class II 2002-05-02
K021120 RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP Arrow Intl., Inc. DQY Class II 2002-05-02
K021088 JOGUIDE CARDIOVASCULAR GUIDING C ATHETER Jomed Catheter, Inc. DQY Class II 2002-05-02
K012614 KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN Medical Instruments Technology, Inc. JOW Class II 2002-05-01
K021217 AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP Biotronik, Inc. DTB Class III 2002-05-01
K011859 KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS Klimamed Technologie Medizingerate GmbH DWJ Class II 2002-05-01
K020350 BCI 3180 PULSE OXIMETER Bci, Inc. DQA Class II 2002-04-30
K020366 GLOBAL ECG MANAGEMENT SYSTEM (GEMS) Cardiocomm Solutions, Inc. DPS Class II 2002-04-30
K021015 ACIST PLUS 4 ANGIOGRAPHIC CATHETER Acist Medical Systems DQO Class II 2002-04-26
K013517 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 Medtronic Vascular DQY Class II 2002-04-25
K020333 ATRION MEDICAL QL FLUID DISPENSING SYRINGE Atrion Medical Products, Inc. DXT Class II 2002-04-25
K010128 COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE Cook Vascular, Inc. DYB Class II 2002-04-25
K020708 PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES Philips Medical Systems, Inc. DPS Class II 2002-04-25
K020257 DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S Datascope Corp. DSP Class II 2002-04-24
K020515 JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA Jostra AG DWF Class II 2002-04-24

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