510(k) Report

Devices descending from K242016

8 later devices reach EnSite™ X EP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+1K252013EnSite™ X EP SystemAbbott Medical20253—
+1K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+1K251234EnSite™ X EP SystemAbbott Medical20254—
+2K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+2K260212EnSite™ X EP SystemAbbott Medical20262—
+3K261729EnSite™ X EP SystemAbbott Medical20260—
+3K262006EnSite™ X EP SystemAbbott Medical20260—