510(k) Report

Devices descending from K201181

18 later devices reach EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+2K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+2K212061EnSite X EP SystemAbbott202113—
+3K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+3K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+3K213364EnSite X EP SystemAbbott Medical202112—
+4K221213EnSite X EP SystemAbbott202211—
+5K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+6K231415EnSite™ X EP SystemAbbott Medical20239—
+7K242016EnSite™ X EP SystemAbbott Medical20248—
+8K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+8K252013EnSite™ X EP SystemAbbott Medical20253—
+8K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+8K251234EnSite™ X EP SystemAbbott Medical20254—
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K260212EnSite™ X EP SystemAbbott Medical20262—
+10K261729EnSite™ X EP SystemAbbott Medical20260—
+10K262006EnSite™ X EP SystemAbbott Medical20260—