510(k) Report

Devices descending from K180238

19 later devices reach CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—
+1K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc.2019161
+2K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+2K213264CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc.202114—
+2K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc.202015—
+3K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…Medtronic, Inc.20245—
+3K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc.20236—
+3K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)Biosense Webster, Inc.20220—
+4K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+4K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc.20235—
+5K252164NorthStar™ Mapping SystemImricor Medical Systems20261—
+5K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc.20252—
+5K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+5K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+5K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+6K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+6K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—
+6K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+6K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—