510(k) Report

Devices descending from K161701

3 later devices reach CARTO ENT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+2K192397TruDi Navigation SystemBiosense Webster202011
+3K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301