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    K Number
    K083194
    Device Name
    VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Date Cleared
    2009-01-16

    (79 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K031891
    Predicate For
    K092789
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VirtuoSaph™ Endoscopic Vein Harvesting System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting including tissue dissection for use in peripheral and coronary artery bypass grafting.

    Device Description

    The system consists of a disposable trocar, dissector, and harvester. The trocar is inserted into the leg incision and stays in place with the clip securely placed on the skin allowing fast conversion between procedural steps. The dissector or harvester rod accesses the saphenous vein by entering the trocar through the port. A reusable endoscope (which is not in the scope of submission) enters the body through dissector or harvester, and has optical components that send an image from inside of the body to a video monitor for the clinician to view. Dissector rod dissects the saphenous vein and surrounding branches. Harvester cauterizes and cuts the branches of the saphenous vein allowing for the harvesting of it.

    AI/ML Overview

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