BEUDAMED
    Product Code: QAN FDA class 3

    Stent, Iliac Vein

    Unknown

    The Stent, Iliac Vein is an implantable metal scaffold delivered via catheter into the iliac vein to maintain luminal patency, used in the treatment of iliac vein obstruction or compression. It is classified as a Class 3 device requiring Premarket Approval (PMA) due to its implantable, life-sustaining role in venous circulation; no regulation number has been assigned. The product code is QAN, reviewed by the Cardiovascular (CV) panel. It is flagged as both an implant and life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QAN
    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

    A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.