510(k) Report

Devices descending from K130215

2 later devices reach Gore Acuseal Vascular Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231505GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.20231—
+2K233551GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.202301