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510(k) Data Aggregation

    K Number
    K220258
    Device Name
    20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
    Manufacturer
    AVIA Vascular
    Date Cleared
    2022-07-14

    (164 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVIA Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ally device is attached to a PIV catheter system for blood sampling into a vacuum tube or syringe.
    Device Description
    The Ally device by Avia Vascular is intended to be attached to a peripheral intravenous (PIV) catheter system for use as a needleless blood draw device into a vacuum tube or syringe. Once attached to a PIV catheter system, the Ally device functions by extending a conduit tube through the internal lumen of the PIV catheter so that the distal tip of the Ally conduit extends beyond the tip of the PIV catheter, allowing for sampling of blood. The Ally device is a sterile, single use device.
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