BEUDAMED
    Product Code: NIO FDA class 3

    Stent, Iliac

    Unknown

    The Iliac Stent is a metal scaffold delivered via catheter into the iliac artery to maintain vessel lumen patency, used to treat iliac artery occlusive disease and restore lower extremity blood flow. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NIO 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
    34
    Registration Numbers
    34
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NIO
    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, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen

    FEI Numbers

    This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.