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510(k) Data Aggregation
K Number
K082093Device Name
BULLSEYE BILIARY STENT SYSTEM
Manufacturer
Date Cleared
2009-07-29
(370 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
SQUAREONE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BullsEye Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Device Description
The BullsEye Biliary Stent System is a 316L stainless steel, balloon-expandable stent design with a 6.2mm diameter and 15mm length (unexpanded). The stent is comprised of a distal cylindrical segment, which provides permanent structural support and subsequently restores and maintains bile flow by scaffolding the duct wall, and a 3.7mm proximal conformable flare segment, which helps to prevent post deployment stent migration and dislocation. The stent is pre-mounted on a dual-balloon, monorail, delivery device with 80cm working length and a crossing profile compatible with guide catheters/introducer sheaths with a minimum inner diameter of 0.081". The system is also compatible with standard 0.014″ guidewires. Two radiopaque marker bands aid in positioning of the stent during the delivery procedure.
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