BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    FFRangio™ System

    Reg #: 3014129161 · FEI: 3014129161 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CATHWORKS LTD.
    Registration Number
    3014129161
    FEI Number
    3014129161
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Rapaport, 4th floor
    City
    Kfar Saba Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K182149

    Owner / Operator

    Firm Name
    CathWorks Ltd.
    Operator Number
    10059615
    Address
    3 Rapaport, 4th floor
    City
    Kfar Saba
    State
    Central
    Postal Code
    4465141
    Country
    IL
    Correspondent
    Ayelet Peer

    US Agent

    Business Name
    Cathworks
    Contact Name
    Jonathan Kim
    Address
    4000 MacArthur Blvd, Suite 1025-East Tower
    City
    Newport Beach
    State
    CA
    ZIP
    92660
    Country
    US
    Email
    [email protected]
    Phone
    888 8892284

    Products

    Device Name Product Code
    Angiographic Coronary Vascular Physiologic Simulation Software QEK

    Proprietary Names

    FFRangio™ System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198