510(k) Report

Devices descending from K964665

2 later devices reach Vascutek Gelweave Vascular Graft (Bifurcated Configuration) through their predicates, nearest generation first.

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