BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Amphirion Deep PTA Catheter

    Reg #: 2183870 · FEI: 2183870 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medtronic, Inc.
    Registration Number
    2183870
    FEI Number
    2183870
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4600 Nathan Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083919

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY

    Proprietary Names

    Amphirion Deep PTA Catheter Amphirion Deep 014" OTW PTA Balloon Catheter (Long Balloon) Amphirion Deep 014” OTW PTA Balloon Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility