510(k) Report

Devices descending from K121351

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+1K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+1K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+2K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+2K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+2K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+3K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+3K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—