510(k) Report

Devices descending from P950022

5 later devices reach TVL (TM) Lead System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093858Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi20101—
+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—
+2K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd20100—