510(k) Report

Devices descending from K110741

4 later devices reach Scepter C Occlusion Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+1K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+1K113698Scepter XC Occlusion Balloon CatheterMicroVention, Inc.20123—
+2K183045Eclipse 2LBalt USA, LLC20190—