510(k) Report

Devices descending from K000248

113 later devices reach Carto EP Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—
+14K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+14K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—
+14K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+15K231415EnSite™ X EP SystemAbbott Medical20239—
+16K242016EnSite™ X EP SystemAbbott Medical20248—
+17K252013EnSite™ X EP SystemAbbott Medical20253—
+17K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+17K251234EnSite™ X EP SystemAbbott Medical20254—
+18K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+18K260212EnSite™ X EP SystemAbbott Medical20262—
+19K261729EnSite™ X EP SystemAbbott Medical20260—
+19K262006EnSite™ X EP SystemAbbott Medical20260—