510(k) Report

Devices descending from K983075

4 later devices reach Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp.19992—
+1K991032Guidant Megalink Biliary Stent, Model FG1002949-58Guidant Corp.19990—
+2K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc.20060—
+2K053459Omnilink .035 Biliary Stent SystemGuidant Corporation20060—