510(k) Report

Devices descending from K252302

2 later devices reach CARTO™ 3 EP Navigation System V8.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+1K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—