510(k) Report

Devices descending from K101667

50 later devices reach Ensite Velocity System Referred to Ensite Velocity System with Positional… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112688Ensite Velocity System V.3.0St Jude Medical201148—
+1K110549Ensite Velocity SystemSt Jude Medical201129—
+2K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical201628—
+2K130727Ensite Velocity SystemSt Jude Medical201329—
+2K130594Ensite Velocity SystemSt Jude Medical201346—
+3K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical201827—
+3K170948AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.201711—
+3K141050Ensite Velocity SystemSt Jude Medical201433—
+4K190131AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20199—
+4K181577AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20190—
+4K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201826—
+4K160218AutoMark ModuleSt Jude Medical201628—
+4K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical201629—
+4K160186EnSite Velocity Surface Electrode KitSt Jude Medical20161—
+5K201094iMap 3D Mapping & Navigation System (iMap System)Cardionxt, Inc.20210—
+5K191392AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20198—
+5K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201825—
+6K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical202018—
+6K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation…Abbott Medical20205—
+6K193013AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20207—
+7K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+7K210680AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20210—
+7K201015AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20205—
+7K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+8K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+8K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+8K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+8K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+8K212061EnSite X EP SystemAbbott202113—
+8K212345AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20214—
+9K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+9K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+9K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+9K220784AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20223—
+9K213364EnSite X EP SystemAbbott Medical202112—
+10K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20222—
+10K221213EnSite X EP SystemAbbott202211—
+11K231091AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—
+11K230606AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—
+11K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+12K231415EnSite™ X EP SystemAbbott Medical20239—
+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—