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

    MEDRAD® Imaging Bulk Package Transfer Spike

    K Number: K253688 · Decision Jun 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    10
    Review Days
    203

    Basic Information

    Device Name
    MEDRAD® Imaging Bulk Package Transfer Spike
    K Number
    K253688
    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 Medical Care, Inc.
    Date Received
    November 21, 2025
    Decision Date
    June 12, 2026
    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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