510(k) Report

Devices descending from K091624

3 later devices reach Stent Graft Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+1K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC20122—
+2K172567GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc.201801