BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GORE® Tri-Lobe Balloon Catheter

    Reg #: 3007284313 · FEI: 3007284313 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    W. L. GORE & ASSOCIATES, INC.
    Registration Number
    3007284313
    FEI Number
    3007284313
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    32360 N. North Valley Parkway
    City
    Phoenix
    State
    AZ
    ZIP
    85085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250410

    Owner / Operator

    Firm Name
    W. L. GORE & ASSOCIATES, INC.
    Operator Number
    9925013
    Address
    1505 North Fourth Street
    City
    Flagstaff
    State
    AZ
    Postal Code
    86004
    Country
    US
    Correspondent
    Lisa Wells

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY

    Proprietary Names

    GORE® Tri-Lobe Balloon Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device