510(k) Report

Devices descending from K013250

3 later devices reach Gore-Tex Vascular Graft; Gore-Tex Stretch Vascular Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202471exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftPeca Labs20202—
+2K221628exGraft, exGraft CarbonPeca Labs20221—
+3K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc.20240—