510(k) Report

Devices descending from K041032

1 later device reach Modification to Lifestent SDS and XL SDS Biliary Endoprosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052132Modification to: Lifestent Valeo Biliary Stent SystemEdwards Lifesciences, LLC20050—