510(k) Report

Devices descending from K213364

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221213EnSite X EP SystemAbbott202211—
+2K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+3K231415EnSite™ X EP SystemAbbott Medical20239—
+4K242016EnSite™ X EP SystemAbbott Medical20248—
+5K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+5K252013EnSite™ X EP SystemAbbott Medical20253—
+5K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+5K251234EnSite™ X EP SystemAbbott Medical20254—
+6K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+6K260212EnSite™ X EP SystemAbbott Medical20262—
+7K261729EnSite™ X EP SystemAbbott Medical20260—
+7K262006EnSite™ X EP SystemAbbott Medical20260—