510(k) Report

Devices descending from K193237

2 later devices reach Carto Octaray Mapping Catheter with Trueref Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211438OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster, Inc.20221—
+2K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyBiosense Webster, Inc.20230—