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510(k) Data Aggregation
K Number
K180919Device Name
GORE Tri-Lumen Catheter
Manufacturer
W.L. Gore and Associates Inc.
Date Cleared
2018-10-05
(179 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
W.L. Gore and Associates Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.
Device Description
The GORE® Tri-Lumen Catheter (TLC) is a 140cm long multi-lumen accessory catheter designed to assist with multiple wire introduction and control during endovascular procedures. The central lumen can accommodate one 0.035" guidewire or two 0.018" guidewires while the two auxiliary lumens can each accommodate one 0.014" quidewire. The trailing end of the device has two distinct extension tubes to assist in the introduction of the guidewires into the auxiliary lumens. The leading end of the device is radiopaque to assist in visibility under fluoroscopy. The GORE® Tri-Lumen Catheter is designed to minimize entanglement of multiple quidewires and facilitate through and through access during cardiovascular procedures with fewer snaring maneuvers.
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