510(k) Report

Devices descending from K221213

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+2K231415EnSite™ X EP SystemAbbott Medical20239—
+3K242016EnSite™ X EP SystemAbbott Medical20248—
+4K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+4K252013EnSite™ X EP SystemAbbott Medical20253—
+4K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+4K251234EnSite™ X EP SystemAbbott Medical20254—
+5K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+5K260212EnSite™ X EP SystemAbbott Medical20262—
+6K261729EnSite™ X EP SystemAbbott Medical20260—
+6K262006EnSite™ X EP SystemAbbott Medical20260—