510(k) Report

Devices descending from K100063

2 later devices reach Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular20101—
+2K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular201308