BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Datascope Corp.

    Reg #: 2248146 · FEI: 1000222374 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    Datascope Corp.
    Registration Number
    2248146
    FEI Number
    1000222374
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15 Law Dr
    City
    FAIRFIELD
    State
    NJ
    ZIP
    07004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041281

    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
    Wire, Guide, Catheter DQX
    Device, Intravascular Catheter Securement KMK
    Introducer, Catheter DYB

    Proprietary Names

    LINEAR 7.5Fr. IAB Catheter & Accessories SENSATION 7Fr. IAB Catheter & Accessories CS300 Intra-Aortic Balloon Pump SENSATION PLUS 7.5Fr. 40cc IAB Catheter & Accessories guidewire SENSATION PLUS 8Fr. 50cc IAB Catheter & Accessories MEGA 8Fr. 50cc IAB Catheter & Accessories STATLOCK IAB Stabilization Device introducer set MEGA 7.5FR. 30cc Intra-Aortic Balloon Catheter & Accessories

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility