510(k) Report

Devices descending from K231207

5 later devices reach CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252164NorthStar™ Mapping SystemImricor Medical Systems20261—
+1K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc.20252—
+2K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—
+2K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+2K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—