510(k) Report

Devices descending from K160187

28 later devices reach Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical201827—
+2K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201826—
+3K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201825—
+4K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical202018—
+4K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation…Abbott Medical20205—
+5K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+5K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+6K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+6K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+6K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+6K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+6K212061EnSite X EP SystemAbbott202113—
+7K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+7K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+7K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+7K213364EnSite X EP SystemAbbott Medical202112—
+8K221213EnSite X EP SystemAbbott202211—
+9K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+10K231415EnSite™ X EP SystemAbbott Medical20239—
+11K242016EnSite™ X EP SystemAbbott Medical20248—
+12K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+12K252013EnSite™ X EP SystemAbbott Medical20253—
+12K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+12K251234EnSite™ X EP SystemAbbott Medical20254—
+13K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+13K260212EnSite™ X EP SystemAbbott Medical20262—
+14K261729EnSite™ X EP SystemAbbott Medical20260—
+14K262006EnSite™ X EP SystemAbbott Medical20260—