BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Sentry IVC filter

    K Number: K162875 · Decision Feb 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    3
    Review Days
    126

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    Basic Information

    Device Name
    Sentry IVC filter
    K Number
    K162875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novate Medical , Ltd.
    Date Received
    October 14, 2016
    Decision Date
    February 17, 2017
    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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    Other Clearances by Novate Medical , Ltd.

    K Number Device Name
    K181202 Sentry IVC Filter
    K173236 Sentry IVC Filter