510(k) Report

Devices descending from K081799

2 later devices reach Gore Tri-Lobe Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243184SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings20250—
+1K250410GORE® Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20250—