meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
51
Latest Decision
2020-04-18

Clearances · page 24 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K200121 Route 92 Medical 088 Access System, 110 cm Route 92 Medical, Inc. QJP Class II 2020-04-18
K192875 Philips Biosensor BX100 Philips Medical Systems DRG Class II 2020-04-16
K200547 Traxcess 14 SELECT Guidewire MicroVention, Inc. MOF Class II 2020-04-16
K193181 Serranator PTA Serration Balloon Catheter Cagent Vascular, LLC PNO Class II 2020-04-15
K192838 Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure Spectrum Medical , Ltd. DWA Class II 2020-04-13
K192850 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Qura S.R.L KFM Class II 2020-04-13
K200634 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Arrow International, Inc. DSP Class II 2020-04-09
K191574 OxSAT 100 S.L.P. , Ltd. DQA Class II 2020-04-09
K191935 Nautilus Smart ECMO Module Mc3 Incorporated BYS Class II 2020-04-09
K193104 Unified Arrhythmia Diagnostic System PocketECG IV Medicalgorithmics S.A. DSI Class II 2020-04-09
K200144 HI-TORQUE Steelcore Bare Guide Wire Abbott Vascular DQX Class II 2020-04-08
K193571 Go2Wire Guide Wire Merit Medical System, Inc. DQX Class II 2020-04-08
K192500 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer Honsun (Nantong) Co., Ltd. DXQ Class II 2020-04-06
K200776 Eko CORE Eko Devices, Inc. DQD Class II 2020-04-06
K192558 Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter Mivi Neurovascular DQY Class II 2020-04-06
K200566 ADAPT Tissue Admedus Regen Pty, Ltd. PSQ Class II 2020-04-03
K200564 Aria System Inova Labs JOW Class II 2020-04-03
K193322 NovaCross CTO Microcatheter Nitiloop , Ltd. DQY Class II 2020-04-02
K192514 Patient Monitor Edan Instruments, Inc. MHX Class II 2020-04-02
K192413 SiteSeal Femoral Compression Device Ensite Vacular, LLC DXC Class II 2020-03-31
K200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES GE Healthcare MHX Class II 2020-03-29
K200499 QuickDraw Venous Cannula Edwards Lifesciences, LLC DWF Class II 2020-03-29
K192732 BodyGuardian Remote Monitoring System Preventice Technologies, Inc. DSI Class II 2020-03-26
K192886 OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip Volcano Corporation DQX Class II 2020-03-26
K193629 Disposable NIBP Cuff Shenzhen Changke Connect Electronics Co., Ltd. DXQ Class II 2020-03-25
K200337 FloPatch (FP120) Flosonics Medical (R/A 1929803 Ontario Corp.) DPW Class II 2020-03-24
K200036 AI-ECG Tracker Shenzhen Carewell Electronics Co., Ltd. DPS Class II 2020-03-20
K191680 AZUR Vascular Plug MicroVention, Inc. KRD Class II 2020-03-20
K193183 ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter Acist Medical Systems, Inc. OBJ Class II 2020-03-20
K191856 Compression Therapy Device Guangzhou Longest Science & Technology Co., Ltd. JOW Class II 2020-03-19
K200379 Super Sheath Togo Medikit Co., Ltd. DRE Class II 2020-03-19
K200198 WIRION Cardiovascular Systems, Inc. NTE Class II 2020-03-18
K200094 speX LP Support Catheter Reflow Medical DQY Class II 2020-03-18
K193310 myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) Abbott (St. Jude Medical) MXC Class II 2020-03-17
K191827 Sunmed Disposable Angio-Closure Pads Sunny Medical Device (Shenzhen) Co., Ltd. DXC Class II 2020-03-16
K200069 Disposable SpO2 Sensor Shenzhen Changke Connect Electronics Co., Ltd. DQA Class II 2020-03-13
K200358 Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula Edwards Lifesciences, LLC DWF Class II 2020-03-13
K193244 Indigo Aspiration System – Lightning Aspiration Tubing Penumbra, Inc. QEW Class II 2020-03-13
K200258 Edwards eSheath Introducer Set Edwards Lifesciences DYB Class II 2020-03-09
K200306 CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit Abbott (Formerly Thoratec Corporation) DWA Class II 2020-03-06
K193147 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System Stereotaxis, Inc. PJB Class II 2020-03-05
K200314 Capere Thrombectomy System Vascular Medcure, Inc. QEW Class II 2020-03-04
K200269 Sapphire II PRO Orbusneich Medical Trading, Inc. LOX Class II 2020-03-04
K183425 CARDIOVIT AT-102 G2 Schiller AG DPS Class II 2020-03-02
K191246 Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) Chalice Medical , Ltd. DTZ Class II 2020-02-28
K200225 Arctic Sun Stat Temperature Management System Medivance, Inc. DWJ Class II 2020-02-28
K191946 Penumbra System Penumbra JET 7X Penumbra, Inc. NRY Class II 2020-02-27
K192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm Medos International SARL QJP Class II 2020-02-27
K193242 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories Masimo Corporation MWI Class II 2020-02-27
K200206 AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter Stryker Neurovascular QJP Class II 2020-02-27
K191402 Heater-Cooler System 3T Livanova Deutschland, GmbH DWC Class II 2020-02-25
K191407 Novalung System Fresenius Medical Care Renal Therapies Group, LLC QJZ Class II 2020-02-21
K191894 Upper Arm Blood Pressure Monitor Shenzhen Zhengkang Technology Co., Ltd. DXN Class II 2020-02-21
K191697 Cardiac Monitor 1500 Zynex Medical, Inc. DSB Class II 2020-02-21
K193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35 Reflow Medical DQY Class II 2020-02-20
K192460 Sentinel Cerebral Protection System Boston Scientific Corporation PUM Class II 2020-02-19
K193012 speX Support Catheter Reflow Medical DQY Class II 2020-02-19
K193466 Swan-Ganz Catheters Edwards Lifesciences, LLC DYG Class II 2020-02-16
K200083 EMBA Hourglass Peripheral Embolization Device (PED) Embolic Acceleration, LLC KRD Class II 2020-02-14
K190882 XenoSure Biologic Patch Lemaitre Vascular PSQ Class II 2020-02-13
K193013 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. DQK Class II 2020-02-11
DEN190038 Surfacer Inside-Out Access Catheter System Bluegrass Vascular Technologies, Inc. QJH Class II 2020-02-10
K192757 VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 Vitalconnect, Inc. DRG Class II 2020-02-06
K191532 The Caterpillar and Caterpillar Micro Arterial Embolization Devices C.R. Bard, Inc. KRD Class II 2020-02-04
K191937 Ezvena IPC, Ezvena SQS Eezcare Medical Corp JOW Class II 2020-01-29
K191323 Carescape B850 GE Healthcare Finland Oy MHX Class II 2020-01-29
K191989 WVSM (Wireless Vital Signs Monitor) RWC + miniCap Athena Gtx MWI Class II 2020-01-29
K191406 KardiaMobile, KardiaStation AliveCor, Inc. DXH Class II 2020-01-24
K193263 Reprocessed Achieve Catheter Connecting Cable Innovative Health, LLC NLH Class II 2020-01-24
K191249 CARESCAPE B450 GE Healthcare Finland Oy MHX Class II 2020-01-24
K192608 Disposable SpO2 Sensor Shenzhen Sino-K Medical Technology Co.,Ltd DQA Class II 2020-01-24
K192092 Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 Seca GmbH & Co. KG DXN Class II 2020-01-23
K191229 TrapIt Imds Operations B.V. DQY Class II 2020-01-21
K191149 CARESCAPE B650 GE Healthcare Finland Oy MHX Class II 2020-01-21
K193548 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular DQX Class II 2020-01-18
K192211 SoundBite Console, SoundBite Active Wire 18 Soundbite Medical Solution, Inc. PDU Class II 2020-01-17
K192415 Study Watch with Irregular Pulse Monitor Verily Life Sciences, LLC DXH Class II 2020-01-17
K193509 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX Acutus Medical, Inc. DYB Class II 2020-01-17
K181089 SureLead Cable System Authentic Medical DSA Class II 2020-01-17
K193507 Merit ONE Snare System Merit Medical Systems, Inc. MMX Class II 2020-01-17
K192454 Wattson Temporary Pacing Guidewire Vascular Solutions DQX Class II 2020-01-15
K191275 All’InCath 035M PTA Balloon Dilatation Catheter Nexstep Medical LIT Class II 2020-01-15
K191266 VitalScan ANS Medeia, Inc. JOM Class II 2020-01-15
K192004 Eko Analysis Software Eko Devices, Inc. MWI Class II 2020-01-15
K191717 Route 92 Medical Sheath System Route 92 Medical, Inc. DQY Class II 2020-01-13
K191692 KardioScreen Imedrix Inc. (Formerly Piitech Inc.) DPS Class II 2020-01-10
K192966 FlowMet Laser Associated Sciences, Inc. DPW Class II 2020-01-10
K193440 ER-REBOA PLUS Catheter Prytime Medical Devices, Inc. MJN Class II 2020-01-09
K191870 VV330 Continuous ECG Platform, VivaLNK Adhesive Patch VivaLNK, Inc. DRG Class II 2020-01-07
K192774 BioCardia 8F Morph DNA Deflectable Guide Catheter Biocardia DQY Class II 2020-01-07
K193125 R2P Destination Slender Guiding Sheath Terumo Medical Corporation DYB Class II 2020-01-06
K191907 OptoWire III Opsens, Inc. DQX Class II 2020-01-02
K192599 ASAHI PTCA Guide Wire ASAHI Gaia Next Asahi Intecc Co., Ltd. DQX Class II 2020-01-02
K192343 Patient Monitor Shenzhen Creative Industry Co., Ltd. DQA Class II 2019-12-31
K191059 Masimo Rad-97 and Accessories Masimo Corporation MWI Class II 2019-12-27
K192135 VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) MicroVention, Inc. DQY Class II 2019-12-24
K193279 Comet II Pressure Guidewire Boston Scientific Corporation DXO Class II 2019-12-23
K192023 Arm Blood Pressure Monitor Truly Instrument Limited DXN Class II 2019-12-23
K191551 RIST Cath Radial Access Long Sheath Rist Neurovascular, Inc. DQY Class II 2019-12-23
K191403 Pulse Oximeter Nonin Medical, Inc. DQA Class II 2019-12-20

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