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510(k) Data Aggregation
K Number
K052286Device Name
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
Manufacturer
THE CATHETER EXCHANGE, INC.
Date Cleared
2005-10-21
(60 days)
Product Code
GBX
Regulation Number
878.4200Why 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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