510(k) Report

Devices descending from K143541

2 later devices reach Relieva SpinPlus Balloon Sinuplasty System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+1K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—