BEUDAMED
    Product Code: NIM FDA class 3

    Stent, Carotid

    Unknown

    The Carotid Stent is a metal scaffold delivered via catheter and placed into the carotid artery to maintain vessel lumen patency, typically used to treat carotid artery stenosis and reduce the risk of stroke. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NIM in the Cardiovascular review panel (no regulation number assigned). The device is flagged as both an implant and life-sustaining/life-supporting, reflecting the critical nature of carotid artery patency for cerebral perfusion.

    View on FDA
    510(k)s
    0
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NIM
    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, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen

    FEI Numbers

    This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.