BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Zipline Access Catheter

    Reg #: 3015701715 · FEI: 3015701715 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PERFUZE
    Registration Number
    3015701715
    FEI Number
    3015701715
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 6 Galway Business Park
    City
    Dangan Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K240711

    Owner / Operator

    Firm Name
    Perfuze
    Operator Number
    10086972
    Address
    Unit 6 Galway Business Park
    City
    Dangan
    State
    Galway
    Postal Code
    H91 W7CP
    Country
    IE
    Correspondent
    Anne-Marie Gannon

    US Agent

    Business Name
    Perfuze Inc
    Contact Name
    Veronica Lewis
    Address
    61 W Palisade Avenue, Suite 2B
    City
    Englewood
    State
    NJ
    ZIP
    07631
    Country
    US
    Email
    [email protected]
    Phone
    551 3556698

    Products

    Device Name Product Code
    Catheter, Percutaneous, Neurovasculature QJP

    Proprietary Names

    Zipline Access Catheter

    Establishment Types

    Manufacture Medical Device