510(k) Report

Devices descending from K081803

12 later devices reach ST. Jude Medical Epicardial Catheter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…St Jude Medical201511—
+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
+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—
+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
+3K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+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—