BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    Reg #: 9612164 · FEI: 3002806434 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDTRONIC IRELAND
    Registration Number
    9612164
    FEI Number
    3002806434
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PARKMORE BUSINESS PARK WEST
    City
    GALWAY
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K061188

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    US Agent

    Business Name
    Medtronic Vascular
    Contact Name
    GERARDINE FINN
    Address
    3576 Unocal Place
    City
    Santa Rosa
    State
    CA
    ZIP
    95403
    Country
    US
    Email
    [email protected]
    Phone
    707 5661548

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    Establishment Types

    Manufacture Medical Device