BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zenith® Dissection Endovascular Stent with the Z-Trak® Plus Introduction System

    Reg #: 3005580113 · FEI: 3005580113 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COOK MEDICAL LLC
    Registration Number
    3005580113
    FEI Number
    3005580113
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    400 DANIELS WAY
    City
    Bloomington
    State
    IN
    ZIP
    47404
    Country
    US

    Regulatory Submissions

    PMA Number
    P180001

    Owner / Operator

    Firm Name
    COOK MEDICAL
    Operator Number
    9090900
    Address
    400 DANIELS WAY, --
    City
    Bloomington
    State
    IN
    Postal Code
    47404
    Country
    US
    Correspondent
    Ed - Sutkowski

    Products

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

    Proprietary Names

    Zenith® Dissection Endovascular Stent with the Z-Trak® Plus Introduction System Zenith® TX2® Dissection Endovascular Graft with Pro-Form® and the Z-Trak® Plus Introduction System-Straight Component Zenith® TX2® Dissection Endovascular Graft with Pro-Form® and the Z-Trak® Plus Introduction System -Tapered Component

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198