510(k) Report

Devices descending from K013022

2 later devices reach Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162794Gelweave Vascular GraftsVascutek, Ltd.20171—
+2K241550Gelweave™ Vascular ProsthesesVascutek, Ltd.202501