510(k) Report

Devices descending from K093942

119 later devices reach Ensite Velocity System V1.3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+11K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20222—
+12K252164NorthStar™ Mapping SystemImricor Medical Systems20261—
+12K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc.20252—
+12K231415EnSite™ X EP SystemAbbott Medical20239—
+12K231091AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—
+12K230606AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—
+13K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—
+13K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+13K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—
+13K242016EnSite™ X EP SystemAbbott Medical20248—
+14K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+14K252013EnSite™ X EP SystemAbbott Medical20253—
+14K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+14K251234EnSite™ X EP SystemAbbott Medical20254—
+15K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+15K260212EnSite™ X EP SystemAbbott Medical20262—
+16K261729EnSite™ X EP SystemAbbott Medical20260—
+16K262006EnSite™ X EP SystemAbbott Medical20260—