510(k) Report

Devices descending from K073041

18 later devices reach Relieva and Relieva Acella Sinus Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+1K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+1K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+1K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc.200947
+2K231818METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd.20230—
+2K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+2K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+2K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+2K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC20160—
+2K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+2K150951aeris Balloon Dialation CatheterBryan Medical, Inc.201511
+2K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+2K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+2K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+2K110218Inspira Air Balloon Dilation SystemAcclarent, Inc.201109
+3K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+3K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+3K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—