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510(k) Data Aggregation

    K Number
    K140603
    Device Name
    ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
    Date Cleared
    2014-07-31

    (143 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAPHENA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Saphena Medical OnePass Endoscopic Vessel Harvesting System is in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.
    Device Description
    The OnePass™ Endoscopic Vessel Harvesting System attaches to existing laparoscopic endoscopes (e.g. 7mm) to provide a means to endoscopically harvest vessels for use in arterial bypass graft procedures. Endoscopic Vessel Harvesting is a procedure that has been in use for approximately 15 years. The OnePass™ device differs in that it provides for single device entry into the body cavity without the need for additional instruments. Also, the distal end effector design allows for excellent visibility and quick thermal ligation of vessel trunks while minimizing trauma to the target vessel.
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