BEUDAMED
    Product Code: QWN FDA class 3

    Stent Graft, Infrapopliteal, Venous Arterialization

    Unknown

    The infrapopliteal stent graft for venous arterialization (product code QWN) is a Class 3 implantable cardiovascular device reviewed by the Cardiovascular panel, designed for performing percutaneous arterialization of the deep veins to restore blood flow in the lower limbs. Requiring PMA as a high-risk device, no regulation number has been assigned. It is both an implant and designated as life-sustaining, reflecting its role in restoring critical blood flow to threatened limbs.

    View on FDA
    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QWN
    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

    Definition

    For performing percutaneous arterialization of the deep veins to restore blood flow in the lower limbs

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.