510(k) Report

Devices descending from P960030

2 later devices reach Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical20091—
+2K191469Biotronik StyletsBiotronik, Inc.20190—