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

    Helo Thrombectomy System

    K Number: K252956 · Decision Dec 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    140
    Applicant Total
    1
    Review Days
    93

    Basic Information

    Device Name
    Helo Thrombectomy System
    K Number
    K252956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endovascular Engineering, Inc.
    Date Received
    September 16, 2025
    Decision Date
    December 18, 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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