BEUDAMED
    Product Code: MCX FDA class 3

    Catheter, Coronary, Atherectomy

    Unknown

    The coronary atherectomy catheter is a cardiovascular device used percutaneously to remove or ablate atherosclerotic plaque from coronary arteries, helping to restore coronary blood flow in patients with obstructive coronary artery disease. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MCX and no regulation number or formal medical specialty has been assigned. The device is not an implant and does not sustain life.

    View on FDA
    510(k)s
    0
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    0
    Years Active
    —

    Research product code MCX 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
    MCX
    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

    FEI Numbers

    This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.