BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Endologix LLC

    Reg #: 3011063223 · FEI: 3011063223 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Endologix LLC
    Registration Number
    3011063223
    FEI Number
    3011063223
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    35 Hammond
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120212
    PMA Number
    P040002

    Owner / Operator

    Firm Name
    Endologix LLC
    Operator Number
    9034802
    Address
    3910 Brickway Blvd
    City
    Santa Rosa
    State
    CA
    Postal Code
    95403
    Country
    US
    Correspondent
    Kathryn Simpson

    Products

    Device Name Product Code
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Introducer, Catheter DYB

    Proprietary Names

    Powerlink System AFX Delivery System AFX Introducer System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device