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510(k) Data Aggregation

    K Number
    K071759
    Device Name
    LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS)
    Date Cleared
    2008-07-30

    (398 days)

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

    LIVE TISSUE CONNECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LTC VAD.400 is an electrosurgical generator coupled with designated LTC electrosurgical instruments for bipolar tissue fusion. The LTC VAD.400 electrosurgical generator and designated LTC electrosurgical instruments (i.e., "the VAD System") are intended for use in open general surgical procedures where ligation of vessels and ducts is desired and as an alternative to mechanical clamping (clips or staples) or suturing. The LTC VAD System can be used on vessels up to 7mm in diameter, on ducts up to 2mm in diameter, and tissue bundles as large as will fit in the jaw electrodes of the instrument. The LTC VAD system has not yet been tested for use in tubal sterilization or tubal coagulation for sterilization procedures; therefore, the company does not recommend the use of the LTC VAD system for such procedures. In addition, LTC recommends against the use of the VAD System for male circumcisions.
    Device Description
    The LTC VAD System consists of: a bipolar electrosurgical generator and two distinct and dedicated electrosurgical instruments.
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