BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Liberant Thrombectomy System

    K Number: K250787 · Decision Jun 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    140
    Applicant Total
    7
    Review Days
    89

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    Basic Information

    Device Name
    Liberant Thrombectomy System
    K Number
    K250787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Ireland
    Date Received
    March 14, 2025
    Decision Date
    June 11, 2025
    Product Code
    QEW
    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
    QEW Peripheral Mechanical Thrombectomy With Aspiration

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