BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HALO60 Ablation Catheter

    Reg #: 3004904811 · FEI: 3004904811 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Covidien llc
    Registration Number
    3004904811
    FEI Number
    3004904811
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3062 Bunker Hill Lane
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112454

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    Products

    Device Name Product Code
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    HALO60 Ablation Catheter Barrx 60 RFA Focal Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility