510(k) Report

Devices descending from K211438

1 later device reach OPTRELL Mapping Catheter with TRUEref Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyBiosense Webster, Inc.20230—