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

    NeVa PV Thrombectomy Device

    K Number: K253407 · Decision Nov 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    55

    Basic Information

    Device Name
    NeVa PV Thrombectomy Device
    K Number
    K253407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Vesalio, Inc.
    Date Received
    September 30, 2025
    Decision Date
    November 24, 2025
    Product Code
    QEX
    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
    QEX Coronary Mechanical Thrombectomy With Aspiration

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