510(k) Report

Devices descending from K241243

3 later devices reach Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+2K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+2K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—