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

    MEDRAD® Imaging Bulk Package Transfer Set

    K Number: K173913 · Decision May 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    MEDRAD® Imaging Bulk Package Transfer Set
    K Number
    K173913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer U.S., LLC
    Date Received
    December 22, 2017
    Decision Date
    May 4, 2018
    Product Code
    PQH
    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
    PQH Iodinated Contrast Media Transfer Tubing Set

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