BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SENSATION PLUS 8Fr. 50cc IAB Catheter & Accessories

    Reg #: 3007965489 · FEI: 3007965489 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Datascope Corp
    Registration Number
    3007965489
    FEI Number
    3007965489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    45 Barbour Pond Drive
    City
    Wayne
    State
    NJ
    ZIP
    07470
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112327

    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

    SENSATION PLUS 8Fr. 50cc IAB Catheter & Accessories

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)