510(k) Report

Devices descending from K060142

3 later devices reach Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162794Gelweave Vascular GraftsVascutek, Ltd.20171—
+1K090987Vascutek Branched GelweaveVascutek, Ltd.200901
+2K241550Gelweave™ Vascular ProsthesesVascutek, Ltd.202501