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

    Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit

    K Number: K240257 · Decision Feb 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    15
    Review Days
    29

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    Basic Information

    Device Name
    Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
    K Number
    K240257
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd
    Date Received
    January 31, 2024
    Decision Date
    February 29, 2024
    Product Code
    DTK
    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
    DTK Filter, Intravascular, Cardiovascular

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