BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EXCOR® Pediatric Ventricular Assist Device

    Reg #: 3008454189 · FEI: 3008454189 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BERLIN HEART, INC.
    Registration Number
    3008454189
    FEI Number
    3008454189
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9391 Grogan's Mill Road, Suite A-6
    City
    The Woodlands
    State
    TX
    ZIP
    77380
    Country
    US

    Regulatory Submissions

    PMA Number
    P160035

    Owner / Operator

    Firm Name
    Berlin Heart, Inc.
    Operator Number
    10039498
    Address
    9391 Grogan's Mill Road, Suite A-6
    City
    The Woodlands
    State
    TX
    Postal Code
    77380
    Country
    US

    Products

    Device Name Product Code
    Ventricular (Assist) Bypass DSQ

    Proprietary Names

    EXCOR® Pediatric Ventricular Assist Device

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198