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

    PowerMidline Catheter

    K Number: K162900 · Decision Dec 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    12
    Applicant Total
    645
    Review Days
    58

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    Basic Information

    Device Name
    PowerMidline Catheter
    K Number
    K162900
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    October 17, 2016
    Decision Date
    December 14, 2016
    Product Code
    PND
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PND Midline Catheter

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