510(k) Report

Devices descending from P960013

3 later devices reach Tendril DX Model 1388T & 1388K Endocardial Pacing Leads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical20091—
+1K080924Mond Rvot Stylet Models 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi20080—
+2K191469Biotronik StyletsBiotronik, Inc.20190—