510(k) Report

Devices descending from K111254

7 later devices reach Relieva Solo Elite Sinus Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+1K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+1K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+1K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+1K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+2K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+2K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—