510(k) Report

Devices descending from P890045

2 later devices reach Gelseal TM Triaxial Vascular Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd.20171—
+2K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.202401