510(k) Report

Devices descending from K212959

4 later devices reach ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.20260—
+1K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+2K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+2K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—