510(k) Report

Devices descending from K033670

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20113—
+1K081799Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20082—
+2K243184SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings20250—
+2K250410GORE® Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.20250—
+2K133026Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc.20130—
+2K123531Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20121—
+2K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc.20122—