BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEGA Ballast Distal Access Platform

    Reg #: 3014162263 · FEI: 3014162263 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BALT USA, LLC
    Registration Number
    3014162263
    FEI Number
    3014162263
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    29 Parker
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242376

    Owner / Operator

    Firm Name
    Balt USA, LLC
    Operator Number
    10041614
    Address
    29 Parker
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Catheter, Percutaneous, Neurovasculature QJP
    Catheter, Percutaneous DQY

    Proprietary Names

    MEGA Ballast Distal Access Platform

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198