BEUDAMED
    FDA Registration Active 🇺🇸 United States

    W. L. GORE & ASSOCIATES, INC.

    Reg #: 3007284313 · FEI: 3007284313 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    W. L. GORE & ASSOCIATES, INC.
    Registration Number
    3007284313
    FEI Number
    3007284313
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    32360 N. North Valley Parkway
    City
    Phoenix
    State
    AZ
    ZIP
    85085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180919
    PMA Number
    P250017

    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
    QTL
    Catheter, Percutaneous DQY
    Shunt, Portosystemic, Endoprosthesis MIR
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Catheter, Intravascular Occluding, Temporary MJN
    Introducer, Catheter DYB
    Dura Substitute GXQ
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH

    Proprietary Names

    GORE® VIABAHN® FORTEGRA Venous Stent GORE® Tri-Lumen Catheter GORE® VIATORR® TIPS Endoprosthesis GORE PRECLUDE pericardial membrane Acuseal Cardiovascular Patch GORE-TEX Cardiovascular Patch GORE® Molding and Occlusion Balloon Catheter GORE DRYSEAL FLEX INTRODUCER SHEATH GORE® PRECLUDE® Dura Substitute GORE TIPS Set GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC) GORE® EXCLUDER® AAA Endoprosthesis GORE® EXCLUDER® Iliac Branch Endoprosthesis GORE® Tri-Lobe Balloon Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility