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

    Aventus Clot Management System

    K Number: K240426 · Decision May 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    194
    Applicant Total
    6
    Review Days
    91

    Basic Information

    Device Name
    Aventus Clot Management System
    K Number
    K240426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inquis Medical
    Date Received
    February 13, 2024
    Decision Date
    May 14, 2024
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    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
    CAC Apparatus, Autotransfusion

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