BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARILLON® Mitral Contour System Implant/Handle

    Reg #: 3005102565 · FEI: 3005102565 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIAC DIMENSIONS, INC.
    Registration Number
    3005102565
    FEI Number
    3005102565
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5540 LAKE WASHINGTON BLVD NE
    City
    Kirkland
    State
    WA
    ZIP
    98033
    Country
    US

    Owner / Operator

    Firm Name
    Cardiac Dimensions Inc
    Operator Number
    10050092
    Address
    5540 Lake Washington Blvd. NE
    City
    Kirkland
    State
    WA
    Postal Code
    98033
    Country
    US
    Correspondent
    Robert Calcote

    Products

    Device Name Product Code
    Mitral Valve Repair Devices NKM

    Proprietary Names

    CARILLON® Mitral Contour System Implant/Handle CARILLON® Curved Delivery Catheter CARILLON® Sizing Catheter

    Establishment Types

    Manufacture Device in the United States for Export Only