BEUDAMED
    Product Code: QWM FDA class 3

    Stent Graft, Bypass, Superficial Femoral Artery

    Unknown

    The bypass stent graft for the superficial femoral artery (product code QWM) is a Class 3 implantable cardiovascular device reviewed by the Cardiovascular panel, intended to bypass stenosis in the superficial femoral artery via the femoral vein. As a Class 3 device, it requires PMA due to the high risks associated with vascular implants. No regulation number has been assigned. It is classified as an implant but is not designated as life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QWM
    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 bypassing stenosis in the superficial femoral artery via the femoral vein

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.