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510(k) Data Aggregation

    K Number
    K222889
    Device Name
    FlowArt® Needle-Free Split Septum Valve
    Manufacturer
    Asset Medikal Tasarim San Tic As.
    Date Cleared
    2023-01-20

    (119 days)

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

    Asset Medikal Tasarim San Tic As.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FlowArt® Needle-Free Split Septum Valve: Needle-free valve is intended for use as an accessory to a vascular access device used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein.
    Device Description
    FlowArt® Needle-Free Split Septum Valve
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