BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEGA 7.5FR. 30cc Intra-Aortic Balloon Catheter & Accessories

    Reg #: 2248146 · FEI: 1000222374 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Datascope Corp.
    Registration Number
    2248146
    FEI Number
    1000222374
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15 Law Dr, Unit #1
    City
    FAIRFIELD
    State
    NJ
    ZIP
    07004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120868

    Owner / Operator

    Firm Name
    Datascope Corp.
    Operator Number
    2221819
    Address
    45 Barbour Pond Drive
    City
    Wayne
    State
    NJ
    Postal Code
    07470
    Country
    US
    Correspondent
    Elliott Jang

    Products

    Device Name Product Code
    System, Balloon, Intra-Aortic And Control DSP

    Proprietary Names

    MEGA 7.5FR. 30cc Intra-Aortic Balloon Catheter & Accessories

    Establishment Types

    Manufacture Medical Device