510(k) Report

Devices descending from K091458

8 later devices reach Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110741Scepter C Occlusion Balloon CatheterMicroVention, Inc.20114—
+1K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular20101—
+1K100063Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide…Ev3, Inc.20102—
+2K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+2K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular201308
+2K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+2K113698Scepter XC Occlusion Balloon CatheterMicroVention, Inc.20123—
+3K183045Eclipse 2LBalt USA, LLC20190—