510(k) Report

Devices descending from K112744

7 later devices reach Sapiens Tip Confirmation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113808The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20126—
+2K141634Nautilus DeltaRomedex International Srl20154—
+2K140345The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20142—
+3K241910Neonav ECG Tip Location SystemNavi Medical Technologies20252—
+3K180560Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc.20181—
+4K260929Neonav ECG Tip Location SystemNavi Medical Technologies20260—
+4K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.20250—