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510(k) Data Aggregation

    K Number
    K083218
    Device Name
    TC ENDO PORT
    Date Cleared
    2009-03-06

    (126 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSCARDIAC THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TC Endo Port has applications in abdominal, thoracic, laparoscopic and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
    Device Description
    TC Endoport trocars are sterile single patient use instruments consisting of a sleeve and obturator in sizes ranging from 5-12 mm in diameter. The TC Endoport obturator is made from plastic, and has a dilator tip which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar sleeve contains two seals, an outer annular seal that accommodates instruments from 5-12 mm in diameter, and an internal seal. Together these seals minimize gas or fluid leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve, or valved luer are provided with standard luer lock fittings, to provide for gas insufflation, desufflation, or infusion and aspiration of fluids.
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