BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Protek Duo 31 Fr RD

    Reg #: 1718850 · FEI: 1718850 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LivaNova USA, INC.
    Registration Number
    1718850
    FEI Number
    1718850
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14401 WEST 65TH WAY
    City
    ARVADA
    State
    CO
    ZIP
    80004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232480

    Owner / Operator

    Firm Name
    LivaNova
    Operator Number
    9003795
    Address
    14401 W 65th Way
    City
    Arvada
    State
    CO
    Postal Code
    80004
    Country
    US

    Products

    Device Name Product Code
    Dual Lumen Ecmo Cannula PZS

    Proprietary Names

    Protek Duo 31 Fr RD Protek Duo 31 Fr Protek Duo 29 Fr

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer)