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510(k) Data Aggregation

    K Number
    K973198
    Device Name
    VGF-7 VASCULAR GRAFT FLOWMETER
    Manufacturer
    Date Cleared
    1998-10-14

    (414 days)

    Product Code
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICARD LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VGF-7 Vascular Graft Flowmeter is device for measuring the flow of saline or other fluid through a graft when driven by a constant steady pressure or a controlled pulsatile pressure. It is indicated during coronary artery bypass surgery for assisting the surgeon in intra-operatively assessing the ability of a given vein graft preparation to support fluid flow. The VGF-7 Vascular Graft Flowmeter is indicated during artery bypass and other blood vessel surgeries for assisting the surgeon in intra-operatively assessing the ability of a given graft preparation to support fluid flow.
    Device Description
    The VGF-7 consists of an automatic syringe that injects blood or saline solution into proximal end of the vein graft at a controlled physiological pressure. The resulting flow rate is displayed on a digital readout. The system consists of a servo mechanism controlled by a microprocessor. The microprocessor activates a controlled pressure loop to maintain a predetermined pressure of liquid in a syringe during injection. The liquid is injected from the syringe through a PVC tube and small graft cannula into the graft. The flowrate is the outcome of the liquid pressure and the graft flow resistance.
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