510(k) Report

Devices descending from K092810

32 later devices reach EP-Workmate System, Version 4.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132073EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical201331—
+2K151911WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical201530—
+3K210392WorkMate Claris SystemAbbott202103
+3K160218AutoMark ModuleSt Jude Medical201628—
+4K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical201827—
+5K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201826—
+6K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201825—
+7K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical202018—
+7K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation…Abbott Medical20205—
+8K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+8K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+9K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+9K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+9K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+9K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+9K212061EnSite X EP SystemAbbott202113—
+10K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+10K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+10K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+10K213364EnSite X EP SystemAbbott Medical202112—
+11K221213EnSite X EP SystemAbbott202211—
+12K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+13K231415EnSite™ X EP SystemAbbott Medical20239—
+14K242016EnSite™ X EP SystemAbbott Medical20248—
+15K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+15K252013EnSite™ X EP SystemAbbott Medical20253—
+15K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+15K251234EnSite™ X EP SystemAbbott Medical20254—
+16K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+16K260212EnSite™ X EP SystemAbbott Medical20262—
+17K261729EnSite™ X EP SystemAbbott Medical20260—
+17K262006EnSite™ X EP SystemAbbott Medical20260—