Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 43
- Latest Decision
- 2021-10-19
Clearances · page 19 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211084 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope | Shanghai Caremate Medical Device Co., Ltd. | DXQ | Class II | 2021-10-19 |
| K212632 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | 2021-10-18 |
| K212593 | ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. | DRF | Class II | 2021-10-15 |
| K210563 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | DXN | Class II | 2021-10-15 |
| K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2021-10-15 |
| K213002 | SCORPION Portal Vein Access Set | Argon Medical Devices | DYB | Class II | 2021-10-14 |
| K211807 | Sapphire NC 24 | OrbusNeich Medical (Shenzhen) Co., Ltd. | LOX | Class II | 2021-10-14 |
| K212908 | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device | Neuravi, Ltd. | NRY | Class II | 2021-10-13 |
| K212876 | Carescape SpO2 - Masimo | Masimo Corporation | DQA | Class II | 2021-10-08 |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Remington Medical, Inc. | DPW | Class II | 2021-10-07 |
| K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2021-10-07 |
| K211475 | Vital Signs Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MWI | Class II | 2021-10-05 |
| K201456 | Scan Monitor | Withings SA | DPS | Class II | 2021-10-05 |
| K211405 | Prelude Guide Sheath | Merit Medical Systems, Inc. | DYB | Class II | 2021-10-04 |
| K210140 | electrocardiograph: SE-1202 | Edan Instruments, Inc. | DPS | Class II | 2021-10-01 |
| K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. | DXN | Class II | 2021-10-01 |
| K210562 | HRSpheres Narrow-Size Embolic Microspheres | Suzhou Hengrui Hongyuan Medical Co., Ltd. | KRD | Class II | 2021-10-01 |
| K212386 | AngioVac F18 85 | AngioDynamics, Inc. | DWF | Class II | 2021-09-30 |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | DXJ | Class II | 2021-09-30 |
| K212227 | Philips MR Patient Care Portal | Invivo Corporation | MWI | Class II | 2021-09-30 |
| K212026 | Amplatzer Steerable Delivery Sheath | ABBOTT MEDICAL | DQY | Class II | 2021-09-27 |
| K212738 | Amplatzer Talisman Delivery Sheath | ABBOTT MEDICAL | DQY | Class II | 2021-09-27 |
| K212725 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | DQY | Class II | 2021-09-24 |
| K212708 | Halo One Thin-Walled Guiding Sheath | C.R. Bard, Inc. | DYB | Class II | 2021-09-23 |
| K210152 | Automatic Digital Blood Pressure Monitor | Aviche Shandong Medical Technology Co, Ltd. | DXN | Class II | 2021-09-23 |
| K211747 | Reusable NIBP Cuff | Shenzhen Coreray Technology Co., Ltd. | DXQ | Class II | 2021-09-23 |
| K212160 | SimpleSENSE Platform | Nanowear, Inc. | DXH | Class II | 2021-09-22 |
| K212287 | Dayspring Lite | Koya Medical, Inc. | JOW | Class II | 2021-09-21 |
| K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | Imperative Care, Inc. | QJP | Class II | 2021-09-20 |
| K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | Medtronic | DTZ | Class II | 2021-09-16 |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | NLH | Class II | 2021-09-15 |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system | Cardiovascular Systems, Inc. | MCW | Class II | 2021-09-14 |
| K211305 | ANNE One | Sibel, Inc. | DRG | Class II | 2021-09-14 |
| K211738 | Rotarex Atherectomy System | C.R. Bard, Inc. | MCW | Class II | 2021-09-14 |
| K211494 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | DRF | Class II | 2021-09-14 |
| K211375 | Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | DRF | Class II | 2021-09-10 |
| K210160 | AlertWatch:AC | Alertwatch, Inc. | MSX | Class II | 2021-09-10 |
| K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | DWM | Class II | 2021-09-09 |
| DEN200030 | FEops HEARTguide | Feops NV | QQI | Class II | 2021-09-08 |
| K211235 | CIRCUL8 Luxe DVT Prevention Device | Ortho8, Inc. | JOW | Class II | 2021-09-08 |
| K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM | Health & Life Co., Ltd. | DXN | Class II | 2021-09-08 |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Applied Medical Resources Corporation | DXE | Class II | 2021-09-07 |
| K211200 | WoundExpress | Huntleigh Healthcare , Ltd. | JOW | Class II | 2021-09-03 |
| K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | MSX | Class II | 2021-09-03 |
| K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | Biotronik, Inc. | DRF | Class II | 2021-09-02 |
| K210032 | Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) | Leadtek Research, Inc. | DQA | Class II | 2021-09-01 |
| K203084 | Ablamap Software | Ablacon, Inc. | DQK | Class II | 2021-08-31 |
| K211041 | Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 | Shenzhen Yuezhongxing Technology Co., Ltd. | DXN | Class II | 2021-08-30 |
| K202752 | AXS Vecta 46 Intermediate Catheter | Stryker Neurovascular | QJP | Class II | 2021-08-27 |
| K212345 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2021-08-27 |
| K210530 | WOLF Thrombectomy System, 6F | Devoro Medical, Inc. | QEW | Class II | 2021-08-27 |
| K211240 | ViperCross Support Catheters | Cardiovascular Systems, Inc. | DQY | Class II | 2021-08-26 |
| K202916 | Balloon Guiding Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | QJP | Class II | 2021-08-25 |
| K210838 | PROWLER SELECT PLUS; PROWLER EX | Medos International SARL | KRA | Class II | 2021-08-25 |
| K212027 | TurboHawk Plus Directional Atherectomy System | Medtronic, Inc. | MCW | Class II | 2021-08-24 |
| K212324 | RenovoCath | Renovorx, Inc. | MJN | Class II | 2021-08-23 |
| K201094 | iMap 3D Mapping & Navigation System (iMap System) | Cardionxt, Inc. | DQK | Class II | 2021-08-16 |
| K211654 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | NRY | Class II | 2021-08-16 |
| K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | DSA | Class II | 2021-08-16 |
| K211588 | Caretaker Platform, VitalStream Platform, CT5 | Caretaker Medical | DXN | Class II | 2021-08-13 |
| K210671 | Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 | Weony (Shenzhen) Technology Co., Ltd. | DXN | Class II | 2021-08-13 |
| K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | MXC | Class II | 2021-08-13 |
| K212228 | WATCHMAN FXD Curve Access System | Boston Scientific Corporation | DQY | Class II | 2021-08-13 |
| K203363 | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | PDU | Class II | 2021-08-12 |
| K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | IZQ | Class II | 2021-08-06 |
| K210680 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2021-08-05 |
| K211893 | SelectFlex Neurovascular Access System Family | Q'Apel Medical, Inc. | QJP | Class II | 2021-08-05 |
| K211068 | PrevisEA Device | Entac Medical, Inc. | DQD | Class II | 2021-08-04 |
| K201246 | PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) | Qualimed USA, LLC | LIT | Class II | 2021-08-03 |
| K210339 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | KRA | Class II | 2021-08-02 |
| K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | QAQ | Class II | 2021-07-30 |
| K211338 | EMBOTRAP III Revascularization Device | Neuravi, Ltd. | NRY | Class II | 2021-07-30 |
| K211492 | Pounce Thrombectomy System | Surmodics,Inc. | QEW | Class II | 2021-07-30 |
| K210274 | Fingertip Pulse Oximeter | Zhuhai Linte Medical Instrument Co., Ltd. | DQA | Class II | 2021-07-30 |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2021-07-30 |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2021-07-29 |
| K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | DTK | Class II | 2021-07-28 |
| K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe Aps | DTK | Class II | 2021-07-28 |
| K211989 | Aveir Introducer | ABBOTT MEDICAL | DYB | Class II | 2021-07-27 |
| K210635 | Route 92 Medical Full Length 088 Access System | Route 92 Medical, Inc. | QJP | Class II | 2021-07-27 |
| K211990 | Rist 071 Radial Access Guide Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY | Class II | 2021-07-27 |
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | Ra Medical Systems,Inc | PDU | Class II | 2021-07-27 |
| K210736 | doctorgram Stethoscope DES-I | Gv Concepts | DQD | Class II | 2021-07-27 |
| K201887 | VS Newborn Heart Rate Monitor | Surepulse Medical Limited | DQA | Class II | 2021-07-23 |
| K210185 | CardioCurve Steerable Sheath | Talon Surgical | DYB | Class II | 2021-07-23 |
| K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | MXD | Class II | 2021-07-22 |
| K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | DRG | Class II | 2021-07-21 |
| K203168 | LifeLens Wireless ECG Monitor | LifeLens Technologies, Inc. | DSH | Class II | 2021-07-20 |
| K211906 | Vital Signs | Oxehealth Limited | QME | Class II | 2021-07-20 |
| K211910 | Z-6 Atrioseptostomy Catheter | NuMED, Inc. | DXF | Class II | 2021-07-19 |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System | Nihon Kohden Corporation | MHX | Class II | 2021-07-16 |
| K211525 | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | KRA | Class II | 2021-07-16 |
| K201100 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | DWF | Class II | 2021-07-15 |
| K210431 | ReCross | Imds Operations B.V. | DQY | Class II | 2021-07-15 |
| K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | Medtronic, Inc. | DSA | Class II | 2021-07-12 |
| K211495 | EOS PMP | Sorin Group Italia S.R.L. | DTZ | Class II | 2021-07-12 |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Natec Medical , Ltd. | LOX | Class II | 2021-07-09 |
| K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | MJN | Class II | 2021-07-09 |
| K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | DQK | Class II | 2021-07-08 |
| K201726 | Arterial Catheter | Haolang Medical USA Corporation | DQY | Class II | 2021-07-07 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.