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

    Gianturco-Roehm Bird’s Nest Vena Cava Filter

    K Number: K161218 · Decision Jul 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    175
    Review Days
    84

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    Basic Information

    Device Name
    Gianturco-Roehm Bird’s Nest Vena Cava Filter
    K Number
    K161218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Incorporated
    Date Received
    April 29, 2016
    Decision Date
    July 22, 2016
    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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