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510(k) Data Aggregation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bard Power-Injectable Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

    When used with the PowerLoc™ Safety Infusion Set, the Bard Power-Injectable Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

    Device Description

    The Bard Power-Injectable Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The Bard Power-Injectable Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen Bard Power-Injectable Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen Bard Power-Injectable Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.

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