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

    Aventus Thrombectomy System

    K Number: K232730 · Decision Nov 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    140
    Applicant Total
    8
    Review Days
    55

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    Basic Information

    Device Name
    Aventus Thrombectomy System
    K Number
    K232730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inquis Medical
    Date Received
    September 7, 2023
    Decision Date
    November 1, 2023
    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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    Other Clearances by Inquis Medical

    K Number Device Name
    K260091 Aventus Introducer Sheath
    K253925 Aventus Thrombectomy System
    K251189 Aventus Thrombectomy System
    K250668 Aventus Thrombectomy System (IM-2100)
    K250202 Aventus Thrombectomy System
    K240426 Aventus Clot Management System
    K240117 Aventus Thrombectomy System (IM-2001/IM-0002)