Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 46
- Latest Decision
- 2018-11-16
Clearances · page 29 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | Lemaitre Vascular | MJN | Class II | 2018-11-16 |
| K180979 | PureFlex Arterial Cannulae | Sorin Group Italia S.R.L. | DWF | Class II | 2018-11-16 |
| K181897 | Reprocessed Marinr Diagnostic EP Catheter | Innovative Health, LLC | NLH | Class II | 2018-11-15 |
| K181831 | IntelliVue Multi-Measurement Module MMX | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2018-11-15 |
| K181998 | CardioBand ECG Event Recorder | Samsung Strategy and Innovation Center (Ssic) | DPS | Class II | 2018-11-15 |
| K182101 | Riptide Aspiration System (React 71 Catheter) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | 2018-11-14 |
| K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package | Snap40, Ltd. | MSX | Class II | 2018-11-14 |
| K182097 | React 71 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY | Class II | 2018-11-14 |
| K172792 | Handheld Pulse Oximeter, Model SP-20 | Shenzhen Creative Industry Co., Ltd. | DQA | Class II | 2018-11-13 |
| K182360 | Teleport Microcatheter | Orbusneich Medical Trading, Inc. | DQY | Class II | 2018-11-09 |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | DXN | Class II | 2018-11-09 |
| K181684 | VAMP Plus Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | KRA | Class II | 2018-11-08 |
| K181918 | CardioInsight Cardiac Mapping System | Medtronic, Inc. | DQK | Class II | 2018-11-08 |
| K182030 | Faros Mobile | Bittium Biosignals , Ltd. | MLO | Class II | 2018-11-08 |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | Omron Healthcare, Inc. | DXN | Class II | 2018-11-08 |
| K182220 | Curbell branded Patient Monitoring Cables | Curbell Medical Products, Inc. | DSA | Class II | 2018-11-07 |
| K182442 | MiniGuard Arterial Safety Valve | Quest Medical, Inc. | MJJ | Class II | 2018-11-06 |
| K181757 | Günther Tulip® Vena Cava Filter Retrieval Set | Cook Incorporated | MMX | Class II | 2018-11-06 |
| K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | DXN | Class II | 2018-11-06 |
| K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | DRY | Class II | 2018-11-02 |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | Omron Healthcare, Inc. | DXN | Class II | 2018-11-02 |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | Bayer Medical Care, Inc. | DXT | Class II | 2018-11-01 |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | Bayer Medical Care, Inc. | DXT | Class II | 2018-11-01 |
| K182914 | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | DRE | Class II | 2018-10-29 |
| K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | Innovative Health, LLC | NLH | Class II | 2018-10-27 |
| K181031 | TSI Transseptal Introducer | Pressure Products Medical Device Manufacturing, LLC | DYB | Class II | 2018-10-26 |
| K180286 | Polyethylene Catheter | Cook Incorporated | DQO | Class II | 2018-10-26 |
| K181936 | DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | DXT | Class II | 2018-10-25 |
| K181354 | 074 Zenith Flex System | Inneuroco, Inc. | NRY | Class II | 2018-10-25 |
| K180275 | VAMP Optima closed blood sampling system | Edwards Lifesciences, LLC | KRA | Class II | 2018-10-24 |
| K180940 | KODEX EPD System | Philips Medical Systems Nederland B.V. | DQK | Class II | 2018-10-24 |
| K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | DQA | Class II | 2018-10-23 |
| K181248 | Comarch e-Care Platform | Comarch Healthcare SA | DRG | Class II | 2018-10-22 |
| K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port | Medtronic, Inc. | DWF | Class II | 2018-10-19 |
| K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott | DQK | Class II | 2018-10-19 |
| K181618 | Reprocessed Torqr Diagnostic EP Catheter | Innovative Health, LLC | NLH | Class II | 2018-10-18 |
| K181942 | Quantum Ventilation Module | Spectrum Medical , Ltd. | DTX | Class II | 2018-10-18 |
| K180240 | Full Automatic(NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | DXN | Class II | 2018-10-17 |
| K182233 | FlowTriever Retrieval/Aspiration System | Inari Medical | QEW | Class II | 2018-10-15 |
| K181651 | Radial Medical Compression System | Radial Medical, Inc. | JOW | Class II | 2018-10-12 |
| K182522 | Penumbra System (Modified 110 Aspiration Tubing) | Penumbra, Inc. | NRY | Class II | 2018-10-12 |
| K180620 | Endophys Pressure Sensing Sheath Kit | Endophys Holdings, LLC | DYB | Class II | 2018-10-12 |
| K181503 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2018-10-11 |
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) | Cormatrix Cardiovascular, Inc. | PSQ | Class II | 2018-10-10 |
| K182531 | ClotTriever Thrombectomy System | Inari Medical | QEW | Class II | 2018-10-10 |
| K182289 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | DXT | Class II | 2018-10-10 |
| K182018 | Bluetooth blood pressure monitor | Shenzhen Kingyield Technology Co., Ltd. | DXN | Class II | 2018-10-06 |
| K180054 | Royal Flush Plus High-Flow Catheter | Cook Incorporated | DQO | Class II | 2018-10-05 |
| K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | MCW | Class II | 2018-10-05 |
| K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | Avenu Medical, Inc. | PQK | Class II | 2018-10-05 |
| K180919 | GORE Tri-Lumen Catheter | W. L. Gore and Associates, Inc. | DQY | Class II | 2018-10-05 |
| K182337 | HYBRID Guidewire | Balt USA, LLC | MOF | Class II | 2018-10-04 |
| K181196 | Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC | DRG | Class II | 2018-10-03 |
| K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | DTR | Class II | 2018-10-01 |
| K173872 | FibriCheck | Qompium NV | DXH | Class II | 2018-09-28 |
| K181088 | TSP Crosser Transseptal Access System | Transseptal Solutions , Ltd. | DYB | Class II | 2018-09-28 |
| K181021 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | KRD | Class II | 2018-09-27 |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | Access Scientific, LLC | DQY | Class II | 2018-09-26 |
| K182315 | Magic Torque DLVR Guidewire | Boston Scientific Corporation | DQX | Class II | 2018-09-26 |
| K181006 | BB-613 Watch Oximeter | Bio-Beat Technologies , Ltd. | DQA | Class II | 2018-09-21 |
| K181726 | Medline Patient Cables and Lead Wires | Medline Industries, Inc. | DSA | Class II | 2018-09-20 |
| K173830 | MAC VU360 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | DPS | Class II | 2018-09-18 |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | Access Scientific, LLC | DYB | Class II | 2018-09-18 |
| K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | NAJ | Class II | 2018-09-17 |
| K181000 | SelectFlex 072 Neurovascular Access System | Q'Apel | DQY | Class II | 2018-09-13 |
| K182226 | AirStrip RPM InvisionHeart Adapter | Airstrip Technologies, Inc. | MWI | Class II | 2018-09-11 |
| DEN180044 | ECG App | Apple, Inc. | QDA | Class II | 2018-09-11 |
| DEN180042 | Irregular Rhythm Notification Feature | Apple, Inc. | QDB | Class II | 2018-09-11 |
| K182196 | Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth | Imediplus, Inc. | DQD | Class II | 2018-09-11 |
| K182232 | Octane Mechanical Thrombectomy System | Vascular Solutions, Inc. | QEZ | Class II | 2018-09-11 |
| K181311 | Philips Hemodynamic Application R1.0 | Philips Medical Systems Nederlands B.V. | MWI | Class II | 2018-09-07 |
| K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | Orantech, Inc. | DQA | Class II | 2018-09-07 |
| K181128 | Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) | Contego Medical, LLC | LIT | Class II | 2018-09-06 |
| K173765 | Surveyor Patient Monitor | Mortara Instrument, Inc. | MHX | Class II | 2018-09-04 |
| K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2018-09-04 |
| K173368 | Reusable & Disposable SpO2 Sensors | Shenzhen Coreray Technology, Ltd. | DQA | Class II | 2018-08-31 |
| K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | DQK | Class II | 2018-08-29 |
| K181104 | Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style | Shenzhen Combei Technology Co., Ltd. | DXN | Class II | 2018-08-29 |
| K173952 | Universal SmartECG | Vectracor, Inc. | DPS | Class II | 2018-08-28 |
| K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter | Abbott Vascular | LOX | Class II | 2018-08-24 |
| K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | Biosense Webster, Inc. | DQK | Class II | 2018-08-24 |
| K173024 | Non-invasive blood pressure measurement systems | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2018-08-22 |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | 2018-08-21 |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs | DSY | Class II | 2018-08-21 |
| K173197 | Reusable NIBP Cuff | Orantech, Inc. | DXQ | Class II | 2018-08-21 |
| K173663 | Electronic Stethoscope DS3011A | Imediplus, Inc. | DQD | Class II | 2018-08-17 |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | Bayer Medical Care, Inc. | DXT | Class II | 2018-08-17 |
| K181923 | Quantum Workstation 12.1 | Spectrum Medical , Ltd. | DRY | Class II | 2018-08-17 |
| K173761 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | NRY | Class II | 2018-08-17 |
| K172492 | Optical Topography System ETG-4100 | Hitachi Healthcare Americas | DQA | Class II | 2018-08-17 |
| K173454 | Multi-parameter Patient Monitor, models C30 | Shenzhen Comen Medical Instruments Co.,Ltd | MHX | Class II | 2018-08-16 |
| K181592 | RAIN Sheath Transradial | Cordis Corporation | DYB | Class II | 2018-08-15 |
| K173123 | Pulse Oximeter | Shenzhen Imdk Medical Technology Co., Ltd. | DQA | Class II | 2018-08-13 |
| K173248 | CARDIOSKIN | Bioserenity Sas | DXH | Class II | 2018-08-11 |
| K180834 | Altrix Precision Temperature Management System | Stryker Medical | DWJ | Class II | 2018-08-10 |
| K180234 | physiQ Heart Rhythm Module | Physiq, Inc. | DPS | Class II | 2018-08-10 |
| K171245 | Presygen/si-1 | Christie Medical Holdings, Inc. | MUD | Class II | 2018-08-09 |
| K180734 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie | MWI | Class II | 2018-08-08 |
| K180805 | Pure EP | Biosig Technologies | DQK | Class II | 2018-08-08 |
| K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length | Imperative Care, Inc. | DQY | Class II | 2018-08-08 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.