510(k) Report

Devices descending from K030638

4 later devices reach Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033393Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp.200335
+2K072708Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions20080—
+2K072720Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc.200816
+3K093947Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc.20100—