510(k) Report

Devices descending from K001237

9 later devices reach Equinox Occlusion Balloon Catheter/System - (10MM Balloon, 4 & 13 MM Tip), (15… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular20101—
+1K091458Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112…Ev3 Neurovascular20098—
+2K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular201308
+2K110741Scepter C Occlusion Balloon CatheterMicroVention, Inc.20114—
+2K100063Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide…Ev3, Inc.20102—
+3K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+3K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+3K113698Scepter XC Occlusion Balloon CatheterMicroVention, Inc.20123—
+4K183045Eclipse 2LBalt USA, LLC20190—