510(k) Report

Devices descending from K011506

4 later devices reach Omnilink .035 Biliary Stent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053459Omnilink .035 Biliary Stent SystemGuidant Corporation20060—
+1K032530Modification to Omnilink .035 Biliary Stent SystemGuidant Corporation200331
+2K033834Omnilink .018 Biliary Stent SystemGuidant Corp.200411
+3K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc.20060—