510(k) Report

Devices descending from K092495

3 later devices reach Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular20101—
+1K100063Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide…Ev3, Inc.20102—
+2K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular201308