510(k) Report

Devices descending from K132297

5 later devices reach EM Sinus Dilation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+1K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+1K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+2K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+2K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—