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    K Number
    K992833
    Device Name
    VACUUM ASSIST STABILIZER
    Manufacturer
    CARDIO THORACIC SYSTEMS
    Date Cleared
    1999-11-10

    (79 days)

    Product Code
    MWS
    Regulation Number
    870.4500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIO THORACIC SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.
    Device Description
    The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.
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    K Number
    K991073
    Device Name
    ACIER SUTURES
    Manufacturer
    CARDIO THORACIC SYSTEMS
    Date Cleared
    1999-07-30

    (121 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIO THORACIC SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acier Steel Suture is indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure. Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure, and certain orthopedic procedures including cerclage and tendon repair.
    Device Description
    Acier Steel Suture is a nonabsorbable sterile surgical suture composed of 316L stainless steel.
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