BEUDAMED
    Product Code: NIP FDA class 3

    Stent, Superficial Femoral Artery

    Unknown

    The Superficial Femoral Artery Stent is a metal scaffold delivered via catheter into the superficial femoral artery to maintain vessel lumen patency, used to treat peripheral arterial disease in the leg. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NIP 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
    38
    Registration Numbers
    38
    Unique Applicants
    0
    Years Active
    —

    Research product code NIP 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
    NIP
    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 -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.