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510(k) Data Aggregation

    K Number
    K240359
    Device Name
    PowerGlide Pro™ Midline Catheter
    Manufacturer
    Becton, Dickinson and Company (Bard Access Systems, Inc.)
    Date Cleared
    2024-07-29

    (174 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Becton, Dickinson and Company (Bard Access Systems, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro™ Midline Catheter is suitable for use with power injectors.
    Device Description
    Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (< 30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen, radiopaque, body-softening polyurethane catheter rated for power injection. Midline catheters, including the PowerGlide Pro, may be considered in patients with difficult IV access as clinically indicated.
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