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510(k) Data Aggregation

    K Number
    K965030
    Device Name
    BRANNON ARTERIO-VENOUS PORTSYRINGE
    Date Cleared
    1997-03-04

    (77 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    fluid aspiration and subsequent transfer of whole blood to vacuum specimen tubes
    Device Description
    The piston syringe, made available in a 6cc size, of this 510(k) notification, known as the Brannon Arterio-Venous PortSyringe, A-VPS, is a combination of two legally marketed devices: (1) a piston syringe, and (2) a blood specimen collection device, BSCD. Additionally, the A-VPS is identical to the Brannon PortSyringe K960049, except the A-VPS includes a centrally disposed inner cannula within its barrel. The BSCD is integral with the plunger unit, with the BSCD communicating with the inner lumen of an attached indwelling catheter via the centrally disposed narrow conduit of the plunger and the centrally disposed inner-cannula within the barrel of the syringe. The fluid collection needle is sealed by a rubber sleeve.
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