BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Highlander 014 PTA Balloon Dilatation Catheter

    Reg #: 9616666 · FEI: 3008906816 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CLEARSTREAM TECHNOLOGIES LTD.
    Registration Number
    9616666
    FEI Number
    3008906816
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Moyne Upper, Enniscorthy
    City
    Wexford
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K223177

    Owner / Operator

    Firm Name
    C. R. Bard, Inc.
    Operator Number
    2212754
    Address
    1 Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

    Device Name Product Code
    Catheter, Angioplasty, Peripheral, Transluminal LIT

    Proprietary Names

    Highlander 014 PTA Balloon Dilatation Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)