BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    pRESET LITE Thrombectomy Device

    Reg #: 3013656790 · FEI: 3013656790 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PHENOX LIMITED
    Registration Number
    3013656790
    FEI Number
    3013656790
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kamrick Court, Ballybrit Business Park
    City
    Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K231539

    Owner / Operator

    Firm Name
    phenox Limited
    Operator Number
    10061667
    Address
    Kamrick Court, Ballybrit Business Park
    City
    Galway
    State
    IE-G
    Postal Code
    H91XY38
    Country
    IE
    Correspondent
    Gary Brogan

    US Agent

    Business Name
    phenox INC
    Contact Name
    Maria Little
    Address
    9842 Research Drive, Irvine
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    844 6743669

    Products

    Device Name Product Code
    Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment POL
    Catheter, Thrombus Retriever NRY

    Proprietary Names

    pRESET LITE Thrombectomy Device

    Establishment Types

    Manufacture Medical Device