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510(k) Data Aggregation

    K Number
    K150059
    Device Name
    BD FlowSmart Set
    Manufacturer
    BECTON, DICKINSON COMPANY
    Date Cleared
    2015-04-28

    (105 days)

    Product Code
    FPA, FPK
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECTON, DICKINSON COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD FlowSmart™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.
    Device Description
    The BD FlowSmart™ set is a subcutaneous administration set intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing. The tubing is connected on one end to the medication reservoir of an external infusion pump and on the other end to the patient, attached to the skin by an adhesive base. It is a single-use sterile device.
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