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

    Permaseal

    K Number: DEN150029 · Decision Jul 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    401

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    Basic Information

    Device Name
    Permaseal
    K Number
    DEN150029
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.4510
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Micro Interventional Devices,Inc.
    Date Received
    June 22, 2015
    Decision Date
    July 27, 2016
    Product Code
    PNQ
    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
    PNQ Apical Closure Device