BEUDAMED
    Product Code: MIR FDA class 3

    Shunt, Portosystemic, Endoprosthesis

    Unknown

    The Portosystemic Endoprosthesis Shunt is an implantable device placed within the hepatic vasculature to create a portosystemic shunt, diverting blood from the portal venous system to the systemic circulation to relieve portal hypertension in patients with cirrhosis or other liver disease. As a Class 3 implantable device, it requires Premarket Approval (PMA) due to the serious risks associated with intravascular implantation and hepatic blood flow alteration. It carries an implant flag, and no regulation number or medical specialty code is recorded.

    View on FDA
    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
    —

    Research product code MIR in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    MIR
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.