Modification to Omnilink .035 Biliary Stent System

• • Terminated Z-1586-05 FDA Unclassified (pre-2012) ·initiated 8 Aug 2005

  This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter.

510(k) Number

K032530 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

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• Modification to Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,

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  Class II

  FDA 510(k) K052274 Active Cleared 21 Sep 2005

See all devices from Guidant Corp. →