BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Turbo-Elite Laser Atherectomy Catheter

    K Number: K250385 · Decision Mar 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    Turbo-Elite Laser Atherectomy Catheter
    K Number
    K250385
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectranetics
    Date Received
    February 11, 2025
    Decision Date
    March 13, 2025
    Product Code
    MCW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MCW Catheter, Peripheral, Atherectomy

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