Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 49
- Latest Decision
- 2019-09-05
Clearances · page 26 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | QEW | Class II | 2019-09-05 |
| K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | DYB | Class II | 2019-09-03 |
| K183438 | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. | DWP | Class II | 2019-09-03 |
| K192058 | EV1000 Clinical Platform NI, EV1000 Clinical Platform | Edwards Lifesciences, LLC | DXN | Class II | 2019-08-30 |
| K191471 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | 2019-08-30 |
| K191664 | SelectFlex 072 Neurovascular Access System | Q'Apel Medical | DQY | Class II | 2019-08-30 |
| K192036 | ClotTriever Thrombectomy System | Inari Medical | QEW | Class II | 2019-08-29 |
| K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | DQK | Class II | 2019-08-29 |
| K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter | Amzetta Technologies Private Limited | MWI | Class II | 2019-08-28 |
| K190437 | Delta 3300 | Netech Corporation | DRL | Class II | 2019-08-28 |
| K191077 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor | Medtronic, Inc. | KFM | Class II | 2019-08-27 |
| K191107 | Plexus | Alleva Medical (D.G), Ltd. | JOW | Class II | 2019-08-27 |
| K191180 | Electronic Blood Pressure Monitor | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | 2019-08-23 |
| K191119 | EkoSonic Endovascular Device | Btg International, Inc. | QEY | Class II | 2019-08-23 |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | DQK | Class II | 2019-08-23 |
| K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | Innovative Health, LLC | NLH | Class II | 2019-08-23 |
| K190792 | BB-613WP | Biobeat Technologies , Ltd. | DQA | Class II | 2019-08-22 |
| K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | DQO | Class II | 2019-08-22 |
| K190207 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | DXN | Class II | 2019-08-19 |
| K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | PJA | Class II | 2019-08-15 |
| K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | PLB | Class II | 2019-08-15 |
| K190852 | Zurich Pressure Guidewire System Model 100 | Zurich Medical, Inc. | DXO | Class II | 2019-08-14 |
| K191731 | Instylla Microcatheter | Instylla, Inc. | KRA | Class II | 2019-08-13 |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | Vascular Solutions, LLC | DQY | Class II | 2019-08-09 |
| K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | Avenu Medical | PQK | Class II | 2019-08-09 |
| K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead | Medtronic | LDF | Class II | 2019-08-08 |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Shockwave Medical, Inc. | PPN | Class II | 2019-08-07 |
| K191606 | RenovoCath | Renovorx, Inc. | MJN | Class II | 2019-08-07 |
| K190893 | Non-invasive Hemodynamic Blood Pressure Monitor | Vita-Course Technologies Co., Ltd. | DXN | Class II | 2019-08-07 |
| K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | 2019-08-07 |
| K190650 | Revolution Centrifugal Blood Pump | Sorin Group Italia S.R.L. | KFM | Class II | 2019-08-07 |
| K183387 | M3290B Patient Information Center iX | Philips Medical Systems | MHX | Class II | 2019-08-06 |
| K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | KRD | Class II | 2019-08-06 |
| K190399 | Beddr 200 System | Hancock Medical, Inc. | DQA | Class II | 2019-08-05 |
| K183305 | Crossing Support Catheter | Tractus Vascular, LLC | DQY | Class II | 2019-08-05 |
| K191546 | Epicardial Access System | Baylis Medical Company, Inc. | DYB | Class II | 2019-08-02 |
| K190338 | 046 Zenith Flex | Inneuroco, Inc. | NRY | Class II | 2019-08-02 |
| K190090 | DynoSense Vital Sign Measuring System | Dynosense Corp. | MWI | Class II | 2019-08-02 |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor | Shenzhen Med-Link Electronics Tech Co., Ltd. | DXN | Class II | 2019-08-02 |
| K190176 | MINAMO | Asahi Intecc Co., Ltd. | DQX | Class II | 2019-08-01 |
| K191469 | Biotronik Stylets | Biotronik, Inc. | DRB | Class II | 2019-08-01 |
| K191190 | Steerable Introducer | Freudenberg Medical, LLC | DYB | Class II | 2019-08-01 |
| K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Medtronic | DRF | Class II | 2019-07-30 |
| K191768 | AXS Vecta Aspiration System | Stryker Neurovascular | NRY | Class II | 2019-07-30 |
| K190132 | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Medtronic | DRF | Class II | 2019-07-30 |
| K190886 | Non-invasive blood pressure measurement systems | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2019-07-29 |
| K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | Asahi Intecc Co., Ltd. | MOF | Class II | 2019-07-26 |
| K190292 | Passio Pump Drainage System | Bearpac Medical | DWM | Class II | 2019-07-25 |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | Abbott Vascular | NTE | Class II | 2019-07-25 |
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model | Access Scientific, LLC | DYB | Class II | 2019-07-25 |
| K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2019-07-22 |
| K182985 | Roadrunner PC Wire Guide, Olcott Torque Device | Cook Incorporated | DQX | Class II | 2019-07-22 |
| K190975 | Plexus SCD110 Sequential Compression Device Sleeve | Midway Medical, LLC | JOW | Class II | 2019-07-22 |
| K182487 | CerusEndo Microcatheter | Cerus Endovascular, Inc. | DQY | Class II | 2019-07-20 |
| K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | DQK | Class II | 2019-07-20 |
| K183349 | AeroDVx System | Sun Scientific, Inc. | JOW | Class II | 2019-07-19 |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit | Acist Medical Systems, Inc. | DXT | Class II | 2019-07-18 |
| K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | DQO | Class II | 2019-07-16 |
| K190749 | 087 Balloon Guide Catheter System | Q'Apel | DQY | Class II | 2019-07-15 |
| K190976 | Radial Medical Compression System | Radial Medical, Inc. | JOW | Class II | 2019-07-12 |
| K191272 | Wearable Device, Wearable Package | Current Health , Ltd. | MSX | Class II | 2019-07-12 |
| K190818 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2019-07-10 |
| K191557 | CentriMag Acute Circulatory Support System | Thoratec Corporation (Now Part of Abbott) | DWA | Class II | 2019-07-10 |
| K183322 | physIQ Heart Rhythm and Respiratory Module | Physiq, Inc. | DPS | Class II | 2019-07-10 |
| K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2019-07-10 |
| K182829 | Scepter Mini Occlusion Balloon Catheter | MicroVention, Inc. | DQY | Class II | 2019-07-10 |
| K183623 | LifeSPARC Pump, LifeSPARC Controller | Cardiacassist, Inc. | KFM | Class II | 2019-07-09 |
| K190594 | AngioVac C20, AngioVac C180 | AngioDynamics, Inc. | DWF | Class II | 2019-07-05 |
| K190548 | BIOMONITOR III, Remote Assistant III | Biotronik, Inc. | MXD | Class II | 2019-07-05 |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Surgical Instrument Service and Savings, Inc. | NLF | Class II | 2019-07-03 |
| K183058 | Arm-type Electronic Blood Pressure Monitor | Shenzhen Bsx Technology Electronics Co., Ltd. | DXN | Class II | 2019-07-03 |
| K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | DQK | Class II | 2019-07-02 |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | MCW | Class II | 2019-07-02 |
| K190351 | Site Seal SV | Ensite Vascular | DXC | Class II | 2019-07-02 |
| K183062 | ASAHI Silverway | Asahi Intecc Co., Ltd. | DQX | Class II | 2019-07-01 |
| K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC | DRF | Class II | 2019-07-01 |
| K190101 | UltraFlex IAB | Arrow International, Inc. | DSP | Class II | 2019-06-28 |
| K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 | Centerpoint Systems | DQY | Class II | 2019-06-28 |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | OBJ | Class II | 2019-06-27 |
| K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Innovative Health, LLC | NLG | Class II | 2019-06-25 |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | 2019-06-25 |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | Centerline Biomedical, Inc. | DQK | Class II | 2019-06-24 |
| K190927 | Oscillometric Blood Pressure Monitor | Rudolf Riester GmbH | DXN | Class II | 2019-06-24 |
| K182844 | ASAHI SASUKE | Asahi Intecc Co., Ltd. | DQY | Class II | 2019-06-22 |
| K190130 | The ClearSight finger cuffs | Edwards Lifesciences, LLC | DXN | Class II | 2019-06-21 |
| K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | DPW | Class II | 2019-06-21 |
| K191209 | Aneroid Type Blood Pressure Kit | Dongguan Mars Medical Products Co., Ltd. | DXQ | Class II | 2019-06-18 |
| K183578 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | KRD | Class II | 2019-06-18 |
| K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | QEW | Class II | 2019-06-17 |
| K190010 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | NRY | Class II | 2019-06-16 |
| K183195 | VIVO | Catheter Precision, Inc. | DQK | Class II | 2019-06-14 |
| K190117 | Fiberoptix IAB | Arrow International, Inc. | DSP | Class II | 2019-06-13 |
| K191089 | Edwards Pressure Cable | Edwards Lifesciences, LLC | DQK | Class II | 2019-06-13 |
| K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UB | Health & Life Co., Ltd. | DXN | Class II | 2019-06-13 |
| K191331 | Life Sensor Cardiac Monitor | Braveheart Wireless, Inc. | DRG | Class II | 2019-06-12 |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | Orbusneich Medical Trading, Inc. | PNO | Class II | 2019-06-11 |
| K182429 | Masimo O3 Regional Oximeter System | Masimo Corporation | MUD | Class II | 2019-06-07 |
| K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | Vitalconnect, Inc. | DRG | Class II | 2019-06-07 |
| K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | Baylis Medical Company, Inc. | DRF | Class II | 2019-06-07 |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | Baylis Medical Company, Inc. | DRF | Class II | 2019-06-07 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.