BEUDAMED
    FDA Registration Active 🇺🇸 United States

    W. L. GORE & ASSOCIATES, INC

    Reg #: 2017233 · FEI: 2017233 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    W. L. GORE & ASSOCIATES, INC
    Registration Number
    2017233
    FEI Number
    2017233
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1505 NORTH FOURTH ST.
    City
    FLAGSTAFF
    State
    AZ
    ZIP
    86004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233551
    PMA Number
    P050006

    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
    Transcatheter Septal Occluder MLV
    Prosthesis, Vascular Graft, Of Less Then 6mm Diameter DYF
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions SDZ
    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions QZK
    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment PFV
    Shunt, Portosystemic, Endoprosthesis MIR
    Stent, Superficial Femoral Artery NIP
    Iliac Covered Stent, Arterial PRL
    Catheter, Percutaneous DQY

    Proprietary Names

    GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder GORE® ACUSEAL Vascular Graft EPTFE Ringed Gore-Tex VG FEP Ringed Gore-Tex Stretch VG GORE® TAG® Thoracic Branch Endoprosthesis GORE® PROPATEN® Vascular Graft GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Gore-Tex Vascular Graft GORE® EXCLUDER® AAA Endoprosthesis GORE® EXCLUDER® Iliac Branch Endoprosthesis GORE® VIATORR® TIPS Endoprosthesis GORE-TEX Vascular Graft GORE-TEX® STRETCH Vascular Graft GORE TAG Conformable Endoprosthesis/GORE TAG Conformable Endoprosthesis with Active Control GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Custom Device GO GORE® Tri-Lumen Catheter Gore-Tex Vascular Graft; Stretch GORE® Tri-Lobe Balloon Catheter Bifurcated Gore-Tex Stretch VG

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198