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510(k) Data Aggregation

    K Number
    K163437
    Device Name
    hypodermic Pinpoint™ GT Needle
    Manufacturer
    C. R. Bard, Inc.
    Date Cleared
    2017-06-23

    (198 days)

    Product Code
    PVZ
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    PVZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hypodermic Pinpoint™ GT Needle is intended for the injection into or the withdrawal of body fluids from parts of the body below the surface of the skin. The needle is to be used with syringes for general purpose fluid injection. The needle tip is echogenic and may be used with ultrasound to provide a visual representation of the needle tip throughout the insertion, medication administration and aspiration process.
    Device Description
    Bard Access Systems, Inc's hypodermic Pinpoint™ GT Needles are designed to inject medication or aspirate fluid. The hypodermic Pinpoint™ GT Needles contain a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The hypodermic Pinpoint™ GT Needles, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion, medication administration and aspiration process. There are four (4) hypodermic Pinpoint™ GT Needle configurations included in this submission, as shown in the table below.
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