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510(k) Data Aggregation

    K Number
    K052286
    Device Name
    DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
    Manufacturer
    THE CATHETER EXCHANGE, INC.
    Date Cleared
    2005-10-21

    (60 days)

    Product Code
    GBX
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE CATHETER EXCHANGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The anti-clog drain is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures.
    Device Description
    The wound drain catheter comprises a proximal drain segment, an internal tubular mesh assembled with a luer fitting adapter, a distal transition tube segment, and a metal trocar.
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