BEUDAMED
    Product Code: NIU FDA class 3

    Stent, Superficial Femoral Artery, Drug-Eluting

    Unknown

    The Superficial Femoral Artery Drug-Eluting Stent is a metal scaffold with a drug coating delivered via catheter into the superficial femoral artery to maintain vessel lumen patency, with the drug coating intended to inhibit restenosis. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NIU in the Cardiovascular review panel (no regulation number assigned). The device is flagged as both an implant and life-sustaining/life-supporting.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NIU
    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

    Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.