Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 52
- Latest Decision
- 2023-10-24
Clearances · page 12 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter | Vein 360, LLC | OWQ | Class II | 2023-10-24 |
| K232570 | Steerant Super Stiff Guidewire | Medtronic Vascular | DQX | Class II | 2023-10-24 |
| K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | DWJ | Class II | 2023-10-24 |
| K230919 | Acumen IQ finger cuff | Edwards Lifesciences, LLC | DXN | Class II | 2023-10-24 |
| K230281 | PICOCLAMP | Kono Seisakusho Co., Ltd. | DXC | Class II | 2023-10-23 |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | NRY | Class II | 2023-10-18 |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | MHX | Class II | 2023-10-17 |
| K232089 | SOZO Pro | ImpediMed Limited | DSB | Class II | 2023-10-17 |
| K232437 | Paragon 8F Balloon Guide Catheter | Wallaby Medical | DQY | Class II | 2023-10-13 |
| K231814 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | OZT | Class II | 2023-10-12 |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. | DXF | Class II | 2023-10-12 |
| K231551 | Stethophone | Sparrow Acoustics, Inc. | DQD | Class II | 2023-10-12 |
| K232574 | VASSALLO GT Crossing14 | Filmec Co. , Ltd. | DQX | Class II | 2023-10-11 |
| K231050 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | DXN | Class II | 2023-10-11 |
| K232578 | VASSALLO GT 018 G12; VASSALLO GT 018 G30 | Filmec Co. , Ltd. | DQX | Class II | 2023-10-11 |
| K232480 | ProtekDuo Veno-Venous Cannula Sets | Cardiacassist, Inc. | PZS | Class II | 2023-10-06 |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | DSI | Class II | 2023-10-06 |
| K223905 | Vivio® LVEDP System | Avicena, LLC | QUO | Class II | 2023-10-06 |
| K232844 | The IQoolTM System | Braincool AB | DWJ | Class II | 2023-10-04 |
| K232767 | Nautilus VF ECMO Oxygenator | Mc3, Inc. | BYS | Class II | 2023-10-04 |
| K232690 | Amulet Steerable Delivery Sheath | ABBOTT MEDICAL | DQY | Class II | 2023-09-29 |
| K223873 | Boppli Infant Blood Pressure Monitor | Pyrames, Inc. | DXN | Class II | 2023-09-29 |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | DRF | Class II | 2023-09-29 |
| K232647 | Microcatheter | Surmodics,Inc. | DQY | Class II | 2023-09-29 |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | QYE | Class II | 2023-09-28 |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | MCW | Class II | 2023-09-27 |
| K231108 | Talon Transseptal Sheath | Inari Medical, Inc. | DYB | Class II | 2023-09-27 |
| K232260 | Thinline Sheath Introducer | Inneuroco, Inc. | DYB | Class II | 2023-09-27 |
| K232609 | Micro Ace Advanced Micro Access System | Merit Medical Systems, Inc. | DRE | Class II | 2023-09-27 |
| K232616 | Volta AF-Xplorer | Volta Medical | DQK | Class II | 2023-09-27 |
| K230884 | AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation | DQK | Class II | 2023-09-26 |
| DEN220026 | VasQ | Laminate Medical Technologies , Ltd. | QVQ | Class II | 2023-09-26 |
| K230184 | Holter ECG and ABP System | Edan Instruments, Inc. | DSH | Class II | 2023-09-25 |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | Edwards Lifesciencess, LLC | DYG | Class II | 2023-09-21 |
| K223913 | Socrates Aspiration System | Scientia Vascular, Inc. | NRY | Class II | 2023-09-20 |
| K222948 | Q Distal Access Catheter | Mivi Neuroscience, Inc. | QJP | Class II | 2023-09-19 |
| K231802 | Millipede 088 Access Catheter | Perfuze, Ltd. | QJP | Class II | 2023-09-19 |
| K231367 | Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) | Shenzhen Finicare Co., Ltd. | DXN | Class II | 2023-09-18 |
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC | DWJ | Class II | 2023-09-15 |
| K223812 | Sensis Vibe (VD15) | Siemens Medical Solutions USA, Inc. | DQK | Class II | 2023-09-15 |
| K230775 | SOFIA EX Intracranial Support Catheter | MicroVention, Inc. | QJP | Class II | 2023-09-14 |
| K230609 | NG Delivery Catheter | Balt USA, LLC | QJP | Class II | 2023-09-13 |
| K221640 | AlloMap Heart Molecular Expression Testing | Caredx, Inc. | OJQ | Class II | 2023-09-13 |
| DEN230021 | ensoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | QXV | Class II | 2023-09-13 |
| K230881 | Change Healthcare Cardiology Hemodynamics | Change Healthcare Israel , Ltd. | MWI | Class II | 2023-09-11 |
| K232686 | CorVista® System | Corvista Health, Inc. | QXX | Class II | 2023-09-08 |
| K231335 | Cleerly ISCHEMIA | Cleerly, Inc. | QXZ | Class II | 2023-09-08 |
| K222823 | AeroDVx Arm System | Sun Scientific, Inc. | JOW | Class II | 2023-09-07 |
| K230649 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | DXN | Class II | 2023-09-07 |
| K231542 | Digital Blood Pressure Monitor WBP Series | Weony (Shenzhen) Technology Co., Ltd. | DXN | Class II | 2023-09-07 |
| K231828 | Pounce Sheath | Surmodics,Inc. | DYB | Class II | 2023-09-07 |
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | DQK | Class II | 2023-09-07 |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. | MMX | Class II | 2023-09-07 |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Masimo Corporation | DQA | Class II | 2023-09-07 |
| DEN230006 | esolution | S4 Medical Corp. | QXU | Class II | 2023-09-06 |
| K230743 | ICHOR 14F Embolectomy System | Ichor | QEW | Class II | 2023-09-05 |
| K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. | QME | Class II | 2023-09-01 |
| K231246 | Ventrax Delivery System (VTR851) | Merit Medical Systems, Inc. | DQY | Class II | 2023-08-30 |
| K231961 | NIBPCuff | Shenzhen Sino-K Medical Technology Co.,Ltd | DXQ | Class II | 2023-08-30 |
| K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | DSH | Class II | 2023-08-30 |
| K232343 | AC3 Series IABP | Arrow International, LLC | DSP | Class II | 2023-08-30 |
| K231276 | SmartCardia 7L Platform | Smartcardia SA | DSI | Class II | 2023-08-30 |
| K221361 | circul pro Ring | Bodimetrics, LLC | DQA | Class II | 2023-08-29 |
| K230159 | SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. | PDU | Class II | 2023-08-28 |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | Vein 360, LLC | OWQ | Class II | 2023-08-25 |
| K222786 | 072 Aspiration System | Q'Apel Medical, Inc. | NRY | Class II | 2023-08-25 |
| K230364 | VitalFlow Console | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | QNR | Class II | 2023-08-25 |
| K230409 | Wrist Type Blood Pressure Monitor (W05,W1101L) | Shenzhen Jamr Technology Co., Ltd. | DXN | Class II | 2023-08-25 |
| K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2023-08-25 |
| K223898 | VitalFlowTM Centrifugal Pump | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | QNR | Class II | 2023-08-25 |
| K231506 | Current Health System | Current Health , Ltd. | MSX | Class II | 2023-08-24 |
| K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | DTQ | Class II | 2023-08-24 |
| K230812 | Withings Scan Monitor 2.0 | Withings | DPS | Class II | 2023-08-23 |
| K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2023-08-22 |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | Medtronic Vascular | DQY | Class II | 2023-08-22 |
| K223560 | Plato 17 Microcatheter | Scientia Vascular, Inc. | QJP | Class II | 2023-08-21 |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | MXD | Class II | 2023-08-19 |
| K230579 | Smart Wedge algorithm | Edwards Lifesciences, LLC | DQK | Class II | 2023-08-18 |
| K223163 | Sleepiz One+ | Sleepiz AG | DRT | Class II | 2023-08-18 |
| K231583 | Route 92 Medical Full Length 054 Access System | Route 92 Medical, Inc. | QJP | Class II | 2023-08-15 |
| K230172 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | 2023-08-12 |
| K230642 | Electronic Blood Pressure Monitor | Dongguan Kangweile Electronic Technology Co., Ltd. | DXN | Class II | 2023-08-11 |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait | Ge Medical Systems Information Technologies, Inc. | MWI | Class II | 2023-08-11 |
| K231415 | EnSite X EP System | ABBOTT MEDICAL | DQK | Class II | 2023-08-10 |
| K223711 | ANNE One | Sibel Health, Inc. | DRG | Class II | 2023-08-10 |
| K223633 | Rubicon Control Support Catheter (H749394323506A1) | Boston Scientific Corporation | DQY | Class II | 2023-08-08 |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | DQO | Class II | 2023-08-08 |
| K230376 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | PNE | Class II | 2023-08-07 |
| K223787 | ECGenius System | Cath Vision Aps | DQK | Class II | 2023-08-04 |
| K232006 | LEGACY® IPC | Ig Technology, Ltd. | JOW | Class II | 2023-08-04 |
| K232132 | LifeSPARC System | Cardiacassist, Inc. | KFM | Class II | 2023-08-03 |
| DEN230003 | Viz HCM | Viz. Ai, Inc. | QXO | Class II | 2023-08-03 |
| K231174 | BPBIO750 | Inbody Co., Ltd. | DXN | Class II | 2023-08-02 |
| K230613 | SKEEPER | Smartsound Corporation | DQD | Class II | 2023-08-02 |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | MOF | Class II | 2023-08-01 |
| K231620 | Nuubo Smart | Smart Solutions Technologies SL | DQK | Class II | 2023-08-01 |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | MSX | Class II | 2023-07-31 |
| K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | DPS | Class II | 2023-07-28 |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | DPS | Class II | 2023-07-28 |
| K231044 | R2P Navicross | Terumo Medical Corporation | DQY | Class II | 2023-07-27 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.