510(k) Report

Devices descending from K151622

11 later devices reach St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…Surgical Instrument Service and Savings, Inc.20240Class I
+1K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service and Savings, Inc.20230Class I
+1K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+1K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+1K182488Reprocessed Response Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+2K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+2K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+2K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+2K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+3K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+3K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—