510(k) Report

Devices descending from K161697

3 later devices reach Acclarent NavWire Sinus Navigation Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190532TruDi NAV WireAcclarent, Inc.20190—
+1K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+2K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—