BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OXY-1 System

    Reg #: 1220648 · FEI: 1220648 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ABIOMED, INC.
    Registration Number
    1220648
    FEI Number
    1220648
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22 Cherry Hill Dr
    City
    DANVERS
    State
    MA
    ZIP
    01923
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223161

    Owner / Operator

    Firm Name
    ABIOMED, INC.
    Operator Number
    1220648
    Address
    22 CHERRY HILL DR., --
    City
    Danvers
    State
    MA
    Postal Code
    01923
    Country
    US
    Correspondent
    Anshul Shah

    Products

    Device Name Product Code
    Control, Pump Speed, Cardiopulmonary Bypass DWA
    Oxygenator, Cardiopulmonary Bypass DTZ
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    OXY-1 System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198