meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2011-04-08

Clearances · page 59 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K110479 ACUITY WHISPER VIEW GUIDE WIRES Boston Scientific Corp DQX Class II 2011-04-08
K101805 HYDROFIX VASO SHIELD Mimedx Group, Inc. OMR Class II 2011-04-08
K103083 AGILIS ES STEERABLE INTRODUCER St Jude Medical DYB Class II 2011-04-08
K102033 COMBITRANS MONITORING SETS AND ACCESSORIES B.Braun Melsungen AG DRS Class II 2011-04-07
K110499 CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR Card Guard Scientific Survival , Ltd. DSI Class II 2011-04-06
K110055 REVERSE MEDICAL REFLEX GUIDE CATHETER Reverse Medical Corporation DQY Class II 2011-04-05
K102726 CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG DTQ Class II 2011-04-04
K110483 MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. DQY Class II 2011-04-04
K102948 TORFLEX TRANSSEPTAL GUIDING SHEATH Baylis Medical Co., Inc. DYB Class II 2011-04-01
K103499 A SCOPE Active Signal Technologies, Inc. DQD Class II 2011-03-31
K110622 INTELLIVUE PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2011-03-31
K103026 ELECTRO SENSOR -BODY COMPOSITION Ld Technology, LLC MNW Class II 2011-03-29
K110526 ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE ZOLL Medical Corporation MKJ Class III 2011-03-25
K103427 MOBILEECG SYSTEM Memtec Corp. DPS Class II 2011-03-24
K103640 MIDMARK IQECG Brentwood Medical Technology Corp. DPS Class II 2011-03-22
K103751 MUSTANG BALLOON DILATATION CATHETERS Boston Scientific LIT Class II 2011-03-22
K103567 LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc. MKJ Class III 2011-03-22
K101422 THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, Inc. DYB Class II 2011-03-22
K110501 HEM-4030 Omron Healthcare, Inc. DXN Class II 2011-03-21
K100424 DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS Danmedical Limited MWI Class II 2011-03-21
K110299 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES Grandway Technology (Shenzhen) Limited DXN Class II 2011-03-21
K110553 ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE Asahi Intecc USA, Inc. DQX Class II 2011-03-18
K102588 ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE Medtronic Ablation Frontiers, LLC DRF Class II 2011-03-18
K110028 MASIMO RADICAL Y PULSE CO-OXIMETER Masimo Corporation DQA Class II 2011-03-17
K110347 DOPPLER MONITOR Cook Vascular, Inc. DPW Class II 2011-03-16
K103686 STAR 50 N Larsen & Toubro Limited MWI Class II 2011-03-15
K110018 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2011-03-15
K103700 ESSENTIAL MRI PATIENT MONITOR Invivo Corporation DQA Class II 2011-03-15
K103763 STELLAR 300 Larsen & Toubro Limited MWI Class II 2011-03-11
K100569 MERIT EMBOLECTOMY CATHETER MODEL ASAP100 Merit Medical Systems, Inc. QEZ Class II 2011-03-11
K110389 STEALTH 360 ORBITAL PAD SYSTEM Cardiovascular Systems, Inc. MCW Class II 2011-03-11
K102919 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE Maquet Cardiopulmonary, AG DTN Class II 2011-03-11
K103134 FUKUDA DENSHI Fukuda Denshi USA, Inc. MHX Class II 2011-03-11
K110503 AIRSTRIP REMOTE PATIENT MONITORING (RPM) Airstrip Technologies, LP MWI Class II 2011-03-10
K110361 ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2011-03-08
K103191 QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING Maquet Cardiopulmonary, AG DTZ Class II 2011-03-08
K101985 ASAHI GUIDE WIRE EXTENSION 165CM Asahi Intecc Co., Ltd. DQX Class II 2011-03-07
K102464 QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING Maquet Cardiopulmonary, AG DTZ Class II 2011-03-04
K102912 INTERLOCK FIBERED IDC OCCLUSION SYSTEM Boston Scientific KRD Class II 2011-03-03
K093830 MEDLINE ANGIOGRAPHIC CONTROL SYRINGE Medline Industries, Inc. DXT Class II 2011-03-03
K110295 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM Boston Scientific Corp KRD Class II 2011-03-03
K103142 SPACELABS MULTI-PARAMETER MODULE Spacelabs Healthcare, Inc. DSI Class II 2011-03-03
K110065 SPAULDING IQ ELECTROCARDIOGRAPH Spaulding Clinical Research, LLC DPS Class II 2011-03-02
K102825 BLOOD PRESSURE CUFF APK Technology Co., Ltd. DXQ Class II 2011-03-02
K103613 INPECTRA STO2 SPOT CHECK Hutchinson Technology, Inc. MUD Class II 2011-03-02
K101876 DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 Shenzhen Biocare Electronics Co., Ltd. DPS Class II 2011-03-01
K101569 V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER Taidoc Technology Corporation DPS Class II 2011-03-01
K102482 FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM Ostial Corporation LIT Class II 2011-02-25
K110241 ENDOLOGIX GUIDEWIRE Techdevice Corporation DQX Class II 2011-02-25
K110163 APPROACH PRO ST WIRE GUIDE Cook Incorporated DQX Class II 2011-02-25
K100799 FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 Contract Medical Intl. GmbH DYB Class II 2011-02-25
K102532 HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING Maquet Cardiopulmonary, AG DWF Class II 2011-02-25
K110193 FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F St. Jude Medical Systems AB DXC Class II 2011-02-24
K103354 EBONY PTA .035 PERIPHERAL DILATATION CATHETER Natec Medical , Ltd. LIT Class II 2011-02-23
K102939 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 Andon Health Co, Ltd. DXN Class II 2011-02-23
K103634 ASCOM CLINICALCONNEX CARDIOMAX Ascom (Us), Inc. MSX Class II 2011-02-23
K102270 ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN Envitec-Wismar GmbH DQA Class II 2011-02-22
K110167 PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) Edwards Lifesciences, LLC DQE Class II 2011-02-18
K103255 VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET Vasonova, Inc. OBJ Class II 2011-02-18
K102968 INFINITY CNAP SMARTPOD Draeger Medical Systems, Inc. DXN Class II 2011-02-18
K103558 SYNTHES SCOUT VESSEL GUARD Synthes Spine OMR Class II 2011-02-18
K102560 REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. NLF Class II 2011-02-18
K103260 VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE Vasonova, Inc. OBJ Class II 2011-02-18
K110330 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2011-02-18
K102206 ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 Mortara Instrument, Inc. DPS Class II 2011-02-18
K110154 ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2011-02-17
K110168 ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2011-02-17
K093610 MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 Concentric Medical, Inc. NRY Class II 2011-02-17
K103678 CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM Ge Medical Systems Information Technologies GmbH DQK Class II 2011-02-16
K110287 PHILIPS ECG LEADWIRE SET Philips Medical Systems DSA Class II 2011-02-15
K102109 ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 Eurosets S.R.L DTZ Class II 2011-02-15
K103693 VANTAGE ABI Summit Doppler Systems, Inc. DXN Class II 2011-02-15
K100184 FUSTAR STEERABLE INTRODUCERS Lifetech Scientific (Shenzhen) Co., Ltd. DQY Class II 2011-02-14
K102714 COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL Boston Scientific Corp KRD Class II 2011-02-11
K103386 MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS Medtronic, Inc. DQY Class II 2011-02-11
K110103 EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER Edwards Lifesciences, LLC DQO Class II 2011-02-11
K110134 NC TREK RX CORONARY DILATATION CATHETER Abbott Vascular-Cardiac Therapies LOX Class II 2011-02-11
K103101 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Abbott Vascular-Cardiac Therapies DQX Class II 2011-02-10
K100225 PULSE OXIMETER MODEL P10 Mediana Co., Ltd. DQA Class II 2011-02-09
K103186 SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES Leonhard Lang GmbH MKJ Class III 2011-02-08
K110192 DEFIBRILLATOR ANALYZER - DA-2006P Bc Group International, Inc. DRL Class II 2011-02-08
K103276 INTEL HEALTH GUIDE Intel Corporation Digital Health Group DRG Class II 2011-02-08
K082254 MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT Bodystat , Ltd. MNW Class II 2011-02-07
K082255 QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT Bodystat , Ltd. MNW Class II 2011-02-07
K101969 MH1 MICROHOLTER RECORDER Exelys, LLC MWJ Class II 2011-02-04
K103732 SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR Spacelabs Healthcare, Ltd. DXN Class II 2011-02-04
K110104 BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM Cincinnati Sub-Zero Products, Inc. DWJ Class II 2011-02-04
K103516 AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 Inovise Medical, Inc. DQD Class II 2011-02-04
K103347 CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES Intervascular Sas DSY Class II 2011-02-02
K103143 ARSTASIS ONE LATCHWIRE ACCESS SYSTEM Arstasis, Inc. DYB Class II 2011-02-02
K110009 ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE Cook, Inc. DQX Class II 2011-02-02
K103113 VASCULAIRE COMPRESSION SYSTEM Venous Health Systems, Inc. JOW Class II 2011-02-02
K101016 ANS SYSTEM Caird Technology DPS Class II 2011-01-28
K103782 4D MV-ASSESSMENT 2.0 Tomtec Imaging Systems GmbH DQK Class II 2011-01-27
K101807 STAYHEALTHY BODY COMPOSITION MONITOR-BCM Stayhealthy, Inc. MNW Class II 2011-01-26
K102792 DISPOSABLE BLOOD PRESSURE CUF Caremate Medical Device Co., Ltd. DXQ Class II 2011-01-26
K103780 MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO Micrus Endovascular Corporation MJN Class II 2011-01-26
K110085 VANTAGE VIEW SYSTEM St Jude Medical DXJ Class II 2011-01-26
K103187 TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM Wildcat Medical, Inc. JOW Class II 2011-01-26
K100875 CEROX, MODEL 321OF Or-Nim Medical , Ltd. MUD Class II 2011-01-25

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