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510(k) Data Aggregation

    K Number
    K252478
    Device Name
    Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port
    Manufacturer
    Bard Access Systems, Inc.
    Date Cleared
    2025-09-05

    (29 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Type
    Special
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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