510(k) Report

Devices descending from K910608

3 later devices reach Permanent Implantable FH Endocardial Leads W/Tip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc.20001—
+1K993139YP 45/15-BP; YP 53/15-BP; YP 60/15-BPBiotronik, Inc.19990—
+2K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc.20030—