510(k) Report

Devices descending from K130727

29 later devices reach Ensite Velocity System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical201628—
+2K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical201827—
+3K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201826—
+4K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201825—
+5K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical202018—
+5K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation…Abbott Medical20205—
+6K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+6K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+7K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+7K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+7K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+7K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+7K212061EnSite X EP SystemAbbott202113—
+8K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+8K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+8K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+8K213364EnSite X EP SystemAbbott Medical202112—
+9K221213EnSite X EP SystemAbbott202211—
+10K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+11K231415EnSite™ X EP SystemAbbott Medical20239—
+12K242016EnSite™ X EP SystemAbbott Medical20248—
+13K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+13K252013EnSite™ X EP SystemAbbott Medical20253—
+13K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+13K251234EnSite™ X EP SystemAbbott Medical20254—
+14K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+14K260212EnSite™ X EP SystemAbbott Medical20262—
+15K261729EnSite™ X EP SystemAbbott Medical20260—
+15K262006EnSite™ X EP SystemAbbott Medical20260—