BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CardioGard Emboli Protection Cannula

    Reg #: 3011427673 · FEI: 3011427673 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIOGARD USA, INC
    Registration Number
    3011427673
    FEI Number
    3011427673
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Business Park Dr. #5
    City
    Tyngsboro
    State
    MA
    ZIP
    01879
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182302

    Owner / Operator

    Firm Name
    CardioGard USA, Inc
    Operator Number
    10048779
    Address
    100 Business Park Dr. #5
    City
    Tyngsboro
    State
    MA
    Postal Code
    01879
    Country
    US
    Correspondent
    Brian S Donlon

    Products

    Device Name Product Code
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    CardioGard Emboli Protection Cannula

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility