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

    GUNTHER TULIP VENA CAVA FILTER

    K Number: K072240 · Decision Nov 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    190
    Review Days
    87

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    Basic Information

    Device Name
    GUNTHER TULIP VENA CAVA FILTER
    K Number
    K072240
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook, Inc.
    Date Received
    August 13, 2007
    Decision Date
    November 8, 2007
    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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