BEUDAMED
    FDA Registration Active 🇺🇸 United States

    On-X Prosthetic Heart Valves

    Reg #: 1063481 · FEI: 3001451326 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Artivion, Inc.
    Registration Number
    1063481
    FEI Number
    3001451326
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1655 Roberts Blvd NW
    City
    Kennesaw
    State
    GA
    ZIP
    30144
    Country
    US

    Regulatory Submissions

    PMA Number
    P000037

    Owner / Operator

    Firm Name
    Artivion, Inc.
    Operator Number
    9003683
    Address
    1655 ROBERTS BLVD., N.W., --
    City
    Kennesaw
    State
    GA
    Postal Code
    30144
    Country
    US
    Correspondent
    Drew Green

    Products

    Device Name Product Code
    Heart-Valve, Mechanical LWQ

    Proprietary Names

    On-X Prosthetic Heart Valves On-X Prosthetic Aortic Heart Valves with Anatomic Sewing Ring On-X AAP Ascending Aortic Prosthesis On-X Conform-X Prosthetic Heart Valves

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198