510(k) Report

Devices descending from K101955

39 later devices reach ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…St Jude Medical201625—
+1K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…St Jude Medical201511—
+1K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter…St Jude Medical201512—
+2K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…Surgical Instrument Service and Savings, Inc.20240Class I
+2K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service and Savings, Inc.20230Class I
+2K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+2K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnabledStryker Sustainability Solutions20200—
+2K192037Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical201918—
+2K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+2K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+2K182488Reprocessed Response Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+2K181458Reprocessed Advisor FL Sensor Enabled Circular Mapping CatheterInnovative Health, LLC20180—
+2K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc.201821—
+3K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+3K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+3K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+3K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+3K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™Abbott Medical20243—
+3K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+3K212776Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC20210—
+3K212061EnSite X EP SystemAbbott202113—
+3K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC20201—
+4K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+4K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+4K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+4K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+4K213364EnSite X EP SystemAbbott Medical202112—
+5K221213EnSite X EP SystemAbbott202211—
+6K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+7K231415EnSite™ X EP SystemAbbott Medical20239—
+8K242016EnSite™ X EP SystemAbbott Medical20248—
+9K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+9K252013EnSite™ X EP SystemAbbott Medical20253—
+9K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+9K251234EnSite™ X EP SystemAbbott Medical20254—
+10K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+10K260212EnSite™ X EP SystemAbbott Medical20262—
+11K261729EnSite™ X EP SystemAbbott Medical20260—
+11K262006EnSite™ X EP SystemAbbott Medical20260—