510(k) Report

Devices descending from K011039

2 later devices reach Omnilink .018 Biliary Stent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc.20060—
+1K033834Omnilink .018 Biliary Stent SystemGuidant Corp.200411