BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Datascope Corp.

    Reg #: 2249723 · FEI: 3001418283 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Datascope Corp.
    Registration Number
    2249723
    FEI Number
    3001418283
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1300 Macarthur Blvd
    City
    MAHWAH
    State
    NJ
    ZIP
    07430
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151254

    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

    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) CARDIOSAVE Li-Ion Battery Transport and Storage Case CS300 CS100/CS100i CS100i Intra-Aortic Balloon Pump CS100 Intra-Aortic Balloon Pump CARDIOSAVE Rescue Intra-Aortic Balloon Pump SENSATION 7Fr. IAB Catheter & Accessories CS300 Intra-Aortic Balloon Pump

    Establishment Types

    Manufacture Medical Device