Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 51
- Latest Decision
- 2017-10-20
Clearances · page 33 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K172090 | GuideLiner V3 Catheter | Vascular Solutions, Inc. | DQY | Class II | 2017-10-20 |
| K170671 | SafeSept Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | DRC | Class II | 2017-10-20 |
| K171206 | D'Vill Introducer | NuMED, Inc. | DYB | Class II | 2017-10-20 |
| K171672 | 065 Zenith, 074 Zenith | Inneuroco, Inc. | DQY | Class II | 2017-10-19 |
| K170298 | Liberator Beacon Tip Locking Stylet | Cook Incorporated | DRB | Class II | 2017-10-18 |
| K172297 | NovaCross Microcatheter | Nitiloop , Ltd. | DQY | Class II | 2017-10-18 |
| K172801 | ECG SENTINEL System | Cardiomedix, Inc. | DXH | Class II | 2017-10-18 |
| K172493 | EnsoETM | Attune Medical | PLA | Class II | 2017-10-17 |
| K170538 | RVS-100 Vital Signs Monitor | Rudolf Riester GmbH | MWI | Class II | 2017-10-17 |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | DRE | Class II | 2017-10-16 |
| K170948 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | 2017-10-16 |
| K170819 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | MTD | Class II | 2017-10-16 |
| K172498 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y | Microlife Intellectual Property GmbH | DXN | Class II | 2017-10-13 |
| K170151 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | DXN | Class II | 2017-10-13 |
| K170154 | Creavo Vitalscan Magnetocardiograph | Creavo Medical Technologies, Ltd. | DPS | Class II | 2017-10-12 |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | Datascope Corp. | DSP | Class II | 2017-10-12 |
| K171373 | 3M Bair Hugger Model 675 Total Temperature Management System | 3M Company | DWJ | Class II | 2017-10-10 |
| K172739 | higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) | Higi Sh, LLC | DXN | Class II | 2017-10-10 |
| K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2017-10-06 |
| K172099 | Shoocin Introducer Kit | Lepu Medical Technology (Beijing) Co., Ltd. | DYB | Class II | 2017-10-05 |
| K171491 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | DYB | Class II | 2017-10-05 |
| K171503 | Reprocessed CristaCath Diagnostic Electrophysiology Catheter | Innovative Health, LLC | NLH | Class II | 2017-10-05 |
| K170506 | ECG Check - Universal, ECG Check - Universal Plus | Cardiac Designs, Inc. | DXH | Class II | 2017-10-02 |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | MXC | Class II | 2017-09-29 |
| K170020 | Peel-Away Introducer Set | Cook Incorporated | DYB | Class II | 2017-09-28 |
| K171936 | Peerbridge Cor(TM) System | Peerbridge Health, Inc. | DSH | Class II | 2017-09-27 |
| K171943 | Electrocardiograph | Edan Instruments, Inc. | DPS | Class II | 2017-09-25 |
| K162956 | NOWCARDIO SYSTEM | Contex International Technologies (Canada), Inc. | QYX | Class II | 2017-09-22 |
| K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | PNO | Class II | 2017-09-22 |
| K172196 | ECOM Cardiac Output Monitoring System | Ecom Medical, Inc. | DSB | Class II | 2017-09-19 |
| K163135 | Finger Pulse Oximeter | Shenzhen Fitfaith Technology Co.,Ltd | DQA | Class II | 2017-09-19 |
| K171176 | M-CATH Microcatheter | Acrostak (Schweiz) AG | DQY | Class II | 2017-09-15 |
| K170417 | Glidewire GT | Terumo Corporation | DQX | Class II | 2017-09-15 |
| K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | MWI | Class II | 2017-09-14 |
| K172117 | Prelude Pursuit Splittable Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | 2017-09-11 |
| K170047 | All-in-One Health Monitor, PC-303 | Shenzhen Creative Industry Co., Ltd. | MWI | Class II | 2017-09-09 |
| K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook | Aln Implants Chirurgicaux | DTK | Class II | 2017-09-08 |
| K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP | Fysicon BV | MWI | Class II | 2017-09-08 |
| K170415 | Medline Hemo-Force DVT Compression Sleeve | Medline Industries, Inc. | JOW | Class II | 2017-09-08 |
| K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter | Creagh Medical | LIT | Class II | 2017-09-08 |
| K170041 | XableCath Support Catheter | Xablecath, Inc. | DQY | Class II | 2017-09-07 |
| K172394 | Steerable Guide Catheter | Abbott Vascular | DRA | Class II | 2017-09-06 |
| K172372 | QuadraSphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | 2017-09-06 |
| K170181 | Prizma | G-Medical Innovations , Ltd. | DXH | Class II | 2017-09-01 |
| K171583 | RhythmView Workstation | Abbott Electrophysiology | DQK | Class II | 2017-09-01 |
| K172033 | Pirouette High Pressure (HP) | Arravasc, Ltd. | LIT | Class II | 2017-08-31 |
| K170467 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | 2017-08-30 |
| K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm | Tricol Biomedical, Inc. | DXC | Class II | 2017-08-29 |
| K170987 | Captus Vascular Retrieval System | Avantec Vascular Corporation | MMX | Class II | 2017-08-28 |
| K172073 | Hi-Torque Command 18 Guide Wire | Abbott Vascular | DQX | Class II | 2017-08-25 |
| K171853 | Liver Access and Biopsy Sets | Cook Incorporated | DYB | Class II | 2017-08-24 |
| K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System | Volcano Atheromed, Inc. | MCW | Class II | 2017-08-24 |
| K170876 | Passport Series Patient Monitors(Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2017-08-23 |
| K171244 | Physiotrace | Nimbleheart, Inc. | DRX | Class II | 2017-08-23 |
| K171452 | MAMBA and MAMBA FLEX Microcatheters | Boston Scientific Corporation | DQY | Class II | 2017-08-21 |
| K171897 | Approach CTO Microwire Guide | Cook Incorporated | DQX | Class II | 2017-08-21 |
| K172182 | QUANTIEN Measurement System | St. Jude Medical (Now Part of the Abbott Medical) | DQK | Class II | 2017-08-18 |
| K171845 | EMBA Hourglass Peripheral Embolization Device | Emba Medical Limited | KRD | Class II | 2017-08-18 |
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip | Coeur, Inc. | DXT | Class II | 2017-08-18 |
| K171406 | Optum TeleHealth Application | United Health Group, Inc. | DRG | Class II | 2017-08-18 |
| K172216 | ACIST RXi Mini System | Acist Medical Systems, Inc. | DRQ | Class II | 2017-08-18 |
| K172220 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DTQ | Class II | 2017-08-17 |
| K163339 | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | Spectralmd, Inc. | DPT | Class II | 2017-08-17 |
| K171793 | Sequential Circulator SC-2004FC-OC | Bio Compression Systems, Inc. | JOW | Class II | 2017-08-17 |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | DWM | Class II | 2017-08-17 |
| K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables | Integral Process Sas | DSA | Class II | 2017-08-16 |
| K172122 | SOZO | ImpediMed Limited | OBH | Class II | 2017-08-11 |
| K171493 | MegaVac Mechanical Thrombectomy System | Capture Vascular, Inc. | QEX | Class II | 2017-08-10 |
| K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm | Biostable Science & Engineering, Inc. | PST | Class II | 2017-08-10 |
| K170488 | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr | Surge Cardiovascular | DWF | Class II | 2017-08-10 |
| K171712 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter 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 | 2017-08-07 |
| K172081 | Maestro Microcatheter | Merit Medical Systems, Inc. | KRA | Class II | 2017-08-04 |
| K171322 | eCareManager 4.1 | Visicu, Inc. | MSX | Class II | 2017-08-03 |
| K170928 | CADence System | Aum Cardiovascular, Inc. | DQD | Class II | 2017-08-03 |
| K170712 | Accutorr 7/VS-900 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | MWI | Class II | 2017-08-02 |
| K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L | Lifewatch Services, Inc. | QYX | Class II | 2017-08-01 |
| K171062 | BP5S Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2017-08-01 |
| K171999 | Performer Introducer | Cook Incorporated | DYB | Class II | 2017-07-31 |
| K161845 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | DXN | Class II | 2017-07-31 |
| K163259 | AXS Offset Delivery Assist Catheter | Stryker Neurovascular | DQY | Class II | 2017-07-28 |
| K171282 | Fully Automatic Blood Pressure Monitor | Andon Health Co, Ltd. | DXN | Class II | 2017-07-27 |
| K171423 | Nasal Alar SpO2 Sensor | Xhale, Inc. | DQA | Class II | 2017-07-27 |
| K163031 | Bunegin-Albin Air Aspiration Set | Cook Incorporated | DXE | Class II | 2017-07-27 |
| K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | DQK | Class II | 2017-07-25 |
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath | Biosense Webster, Inc. | DYB | Class II | 2017-07-25 |
| K171913 | Rubicon 14, 18 and 35 Support Catheters | Boston Scientific Corporation | DQY | Class II | 2017-07-25 |
| K170223 | Progreat | Ashitaka Factory of Terumo Corporation | DQO | Class II | 2017-07-21 |
| K170532 | True Form Reshapable Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | 2017-07-21 |
| K170775 | Mini Stick ENVI Non-Vascular Introducer Kit | AngioDynamics, Inc. | DYB | Class II | 2017-07-19 |
| K170182 | CARDIOVIT FT-1 | Schiller AG | DPS | Class II | 2017-07-19 |
| K171290 | Vela RX PTA Balloon Dilatation Catheter | Curatia Medical | LIT | Class II | 2017-07-19 |
| K171149 | Altrix Temperature Management Wraps | Stryker Medical | DWJ | Class II | 2017-07-18 |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | Vascutek, Ltd. | DSY | Class II | 2017-07-14 |
| K170798 | Dictum Health | Dictum Health, Inc. | MWI | Class II | 2017-07-14 |
| K171029 | eCareCoordinator | Visicu, Inc. | DRG | Class II | 2017-07-14 |
| K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter | Innovative Health, LLC | OWQ | Class II | 2017-07-12 |
| K170814 | Devon 24 | Devon Medical Products (Jiangsu), Ltd. | JOW | Class II | 2017-07-11 |
| K163353 | Needle's Eye Snare Retrieval Set - 54cm | Cook Incorporated | DXE | Class II | 2017-07-11 |
| K163648 | Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series | Grandway Technology (Shenzhen) Limited | DXN | Class II | 2017-07-07 |
| K170941 | RX NC Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | LOX | Class II | 2017-07-07 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.