510(k) Report

Devices descending from K212061

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213364EnSite X EP SystemAbbott Medical202112—
+2K221213EnSite X EP SystemAbbott202211—
+3K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+4K231415EnSite™ X EP SystemAbbott Medical20239—
+5K242016EnSite™ X EP SystemAbbott Medical20248—
+6K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+6K252013EnSite™ X EP SystemAbbott Medical20253—
+6K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+6K251234EnSite™ X EP SystemAbbott Medical20254—
+7K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+7K260212EnSite™ X EP SystemAbbott Medical20262—
+8K261729EnSite™ X EP SystemAbbott Medical20260—
+8K262006EnSite™ X EP SystemAbbott Medical20260—