BEUDAMED
    Product Code: NIQ FDA class 3

    Coronary Drug-Eluting Stent

    Unknown

    The Coronary Drug-Eluting Stent is a metal scaffold with a drug coating placed via catheter into the coronary artery or saphenous vein graft to maintain lumen patency; the drug coating is intended to inhibit restenosis following stent placement. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NIQ in the Cardiovascular review panel (no regulation number assigned). The device is flagged as both an implant and life-sustaining/life-supporting, reflecting its role in treating coronary artery disease.

    View on FDA
    510(k)s
    0
    FEI Numbers
    31
    Registration Numbers
    31
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NIQ
    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, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.

    FEI Numbers

    This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.