510(k) Report

Devices descending from K033212

2 later devices reach Lifestent SDS Biliary Endoprosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052132Modification to: Lifestent Valeo Biliary Stent SystemEdwards Lifesciences, LLC20050—
+1K040550Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies20041—