BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ultraxx Nephrostomy Balloon with TFE Sheath

    Reg #: 1820334 · FEI: 1820334 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Cook Incorporated
    Registration Number
    1820334
    FEI Number
    1820334
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    750 DANIELS WAY
    City
    Bloomington
    State
    IN
    ZIP
    47404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171601

    Owner / Operator

    Firm Name
    COOK, INC.
    Operator Number
    1820334
    Address
    750 DANIELS WAY
    City
    Bloomington
    State
    IN
    Postal Code
    47404
    Country
    US

    Products

    Device Name Product Code
    Catheter, Nephrostomy LJE

    Proprietary Names

    Ultraxx Nephrostomy Balloon with TFE Sheath Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath with Radiopaque Stripe

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198