meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
2013-08-27

Clearances · page 49 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K132360 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER Covidien JOW Class II 2013-08-27
K123797 NT1D VITAL SIGNS MONITOR New Tech, Inc. DQA Class II 2013-08-27
K130516 CARDIODAY Getemed Medizin- Und Informationstechnik AG DQK Class II 2013-08-23
K131978 SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL Biotronik, Inc. DQY Class II 2013-08-23
K130798 PRE-FORMED GUIDEWIRES Lake Region Medical, Inc. DQX Class II 2013-08-23
K131085 CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 Mespere Lifesciences, Inc. PFA Class II 2013-08-22
K130714 PROGIGY SUPPORT CATHETER Radius Medical, LLC DQY Class II 2013-08-22
K130454 LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR Physio-Control, Inc. MKJ Class III 2013-08-21
K132263 AXERA 2 ACCESS SYSTEM Arstasis, Inc. DYB Class II 2013-08-19
K131829 INTELLIVUE PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2013-08-16
K123830 INTERMITTENT PNEUMATIC COMPRESSION DEVICE Dalian Labtek Science & Development Co., Ltd. JOW Class II 2013-08-16
K131478 CONTRAST CONSERVATION SYSTEM Osprey Medical, Inc. DXT Class II 2013-08-15
K131144 AMECO SHEATH INTRODUCER Ameco Medical Industries DYB Class II 2013-08-15
K131063 AMPLATZER TORQ VUE LP DELIVERY SYSTEM St Jude Medical DQY Class II 2013-08-15
K130687 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER Medical Components, Inc. DYB Class II 2013-08-15
K130602 LASSO NAV DUO LOOP CATHETER Biosense Webster, Inc. DRF Class II 2013-08-14
K123882 AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR Ageless Health Industrial DXN Class II 2013-08-14
K123473 HOPER PTCA BALLOON CATHETER Lepu Medical Technology (Beijing) Co., Ltd. LOX Class II 2013-08-13
K132197 CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER Pendracare International, B.V. DQY Class II 2013-08-12
K131032 PHILIPS SURESIGNS CENTRAL Philips Medical Systems MHX Class II 2013-08-12
K130821 INTEL-GE CARE INNOVATIONS CONNECT RCM Intel-Ge Care Innovations, LLC DRG Class II 2013-08-09
K131869 PTS-X SIZING BALLOON CATHETER NuMED, Inc. MJN Class II 2013-08-08
K131450 FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 Ostial Corporation LOX Class II 2013-08-06
K132190 EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. MGZ Class II 2013-08-05
K131493 SIDEKICK AND USHER SUPPORT CATHETERS C.R. Bard, Inc. DQY Class II 2013-08-02
K123571 CARDIO VISION MICS AORTIC CLAMPS Cardiomedical GmbH DXC Class II 2013-08-01
K131079 CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC Creganna Medical Devices DYB Class II 2013-08-01
K132008 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP Medtronic, Inc. DTD Class II 2013-07-30
K124000 MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM Medapps Inc., Dba Alere Connect DRG Class II 2013-07-30
K122458 VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM Cello Partnership D/B/A Verizon Wireless DRG Class II 2013-07-30
K131710 MERIT HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc. DQX Class II 2013-07-29
K130855 PTFE SUPER SHEATH INTRODUCER Martech Medical Products DYB Class II 2013-07-29
K130381 ANGIOJET ULTRA POWER PULSE KIT Medrad, Inc. QEW Class II 2013-07-29
K131361 WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET Covidien DWJ Class II 2013-07-29
K122659 VDRIVE W/V-SONO Stereotaxis, Inc. DQX Class II 2013-07-26
K130785 SEER 1000 Getemed Medizin- Und Informationstechnik AG MWJ Class II 2013-07-26
K131812 SENSIS, SENSIS LITE Siemens Medi Cal Solutions, Inc. DQK Class II 2013-07-25
K131964 BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE Medtronic, Inc. DWA Class II 2013-07-24
K131561 SAM JUNCTIONAL TOURNIQUET Sam Medical Products DXC Class II 2013-07-24
K123714 EDWARDS EMBOL-X INTRODUCER SHEATH Edwards Lifesciences, LLC DYB Class II 2013-07-24
K131742 HEM-6131 Omron Healthcare, Inc. DXN Class II 2013-07-24
K130740 NIGHTINGALE MONITORING SYSTEM Zoe Medical, Inc. MWI Class II 2013-07-23
K131816 SORIN CONNECT DATA MANAGEMENT SYSTEM Sorin Group Deutschland GmbH DXJ Class II 2013-07-23
K130207 SPACELABS HEALTHCARE CARDIOEXPRESS Spacelabs Healthcare, Ltd. DPS Class II 2013-07-23
K130750 RHYTHMIA MAPPING SYSTEM Rhythmia Medical, Inc. DQK Class II 2013-07-22
K131306 IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE Bio Compression Systems, Inc. JOW Class II 2013-07-22
K131572 MICRO AMBULATORY ECG RECORDER Dimetek Digital Medical Technologies, Ltd. DPS Class II 2013-07-22
K131332 CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER Cardiosolutions, Inc. DYB Class II 2013-07-19
K131203 IHEALTH CLOUD Andon Health Co, Ltd. DXN Class II 2013-07-19
K130079 MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER Reflectance Medical, Inc. MUD Class II 2013-07-19
K131179 CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR Thoratec Corp DWA Class II 2013-07-18
K131046 VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF) Venous Health Systems, Inc. JOW Class II 2013-07-18
K131327 BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM Bio Compression Systems, Inc. JOW Class II 2013-07-18
K130766 ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE Cook, Inc. DQX Class II 2013-07-17
K130536 EXPORT ADVANCE ASPIRATION CATHETER Medtronic, Inc. QEZ Class II 2013-07-16
K131763 TRUSCOPE SERIES PATIENT MONITOR Guangdong Biolight Meditech Co., Ltd. MHX Class II 2013-07-15
K130360 CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION Constant Care, LLC DRG Class II 2013-07-15
K131382 EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL Invivo Corporation MWI Class II 2013-07-15
K130339 CLINICAL ALERT NOTIFICATION Extension , Inc. MSX Class II 2013-07-11
K123881 HEARTSINE SAMARITAN PAD 350P Heartsine Technologies, Inc. MKJ Class III 2013-07-11
K130391 EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT Boston Scientific Corp LOX Class II 2013-07-10
K131269 DLP CORONARY OSTIAL PERFUSION CANNULAE Medtronic, Inc. DWF Class II 2013-07-10
K131463 WRIST AUTOMATIC BLOOD PRESSURE MONITOR Honsun (Nantong) Co., Ltd. DXN Class II 2013-07-08
K130676 AMBIO REMOTE HEALTH MONITORING SYSTEM Arrayent Health, LLC D/B/A Ambio Health DRG Class II 2013-07-08
K131666 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING Maquet Cardiopulmonary, AG DWF Class II 2013-07-05
K131573 CP150 ELECTROCARDIOGRAPH Welch Allyn, Inc. DPS Class II 2013-07-03
K123074 IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2013-07-03
K131786 AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER Airstrip Technologies, LP MWI Class II 2013-07-03
K123803 REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM Reverse Medical Corporation KRD Class II 2013-07-02
K131002 VIDA PTV DILATATON CATHETER C.R. Bard, Inc. OMZ Class II 2013-07-02
K131743 CIRONA DVT FOOT GARMENT Devon Medical, Inc. JOW Class II 2013-07-01
K130300 HEATER-COOLER UNIT HCU 40 Maquet Cardiopulmonary, AG DWC Class II 2013-07-01
K131509 ZOE FLUID STATUS MONITOR Noninvasive Medical Technologies, Inc. DSB Class II 2013-06-28
K122917 CODA BALLOON CATHETER Cook, Inc. DQY Class II 2013-06-28
K130584 MONITOR B40 Ge Medical Systems China Co., Ltd. MHX Class II 2013-06-26
K121628 EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) Epi Mobile Health Solutions (S) Pte, Ltd. DXH Class II 2013-06-25
K130850 PRIMI AND SECONDI SUPPORT CATHETERS Thermopeutix, Inc. DQY Class II 2013-06-25
K123842 LAWMAX DILATOR Lifetech Scientific (Shenzhen) Co., Ltd. DRE Class II 2013-06-24
K131092 STEALTH 360 ORBITAL PAD SYSTEM Cardio Systems, Inc. MCW Class II 2013-06-24
K131287 CARDIOSLEEVE Rijuven Corp DQD Class II 2013-06-24
K124038 BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) Bedside Clinical Systems, Inc. MWI Class II 2013-06-21
K120727 MFM-CMS CENTRAL MONITORING SYSTEM Edan Instruments, Inc. MHX Class II 2013-06-21
K131288 VERRATA PRESSURE GUIDE WIRE Volcano Corporation DQX Class II 2013-06-21
K130397 ARROW GPSCATH BALLOON DILATATION CATHETER Hotspur Technologies LIT Class II 2013-06-20
K130722 AIRCAST VENAFLOW ELITE SYSTEM Djo, LLC JOW Class II 2013-06-20
K122763 PHYSIOLOGICAL DATA PROCESSOR Zephyr Technology Corporation DRG Class II 2013-06-20
K130566 BASIXTOUCH Merit Medical Systems, Inc. MAV Class II 2013-06-19
K131395 TRANSTEK BLOOD PRESSURE MONITOR Guangdong Transtek Medical Electronics Co., Ltd. DXN Class II 2013-06-19
K130564 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR Health & Life Co., Ltd. DXN Class II 2013-06-19
K130563 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR Health & Life Co., Ltd. DXN Class II 2013-06-18
K131193 ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM Tactile Systems Technology, Inc. JOW Class II 2013-06-18
K130577 AZUR PUSHABLE 18 & 35 SYSTEM MicroVention, Inc. KRD Class II 2013-06-17
K130414 CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 Trireme Medical, Inc. LIT Class II 2013-06-15
K131569 PG-800A SERIES Shenzhen Pango Electronic Co., Ltd. DXN Class II 2013-06-14
K130849 INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2013-06-14
K130104 GUIDEWIRE, PURSUER SERIES Oscor, Inc. DQX Class II 2013-06-13
K120892 DISPOSABLE 330PSI EXTENSION LINES Coeur, Inc. DXT Class II 2013-06-10
K131300 THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, LLC DYB Class II 2013-06-07
K130259 BEARING NSPVA EMBOLIZATION PARTICLES Merit Medical Systems, Inc. NAJ Class II 2013-06-07
K130791 PRELUDE SHEATH INTRODUCER Merit Medical Systems, Inc. DRE Class II 2013-06-07

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