510(k) Report

Devices descending from K170600

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc.201819—
+2K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—
+2K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc.2019161
+3K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+3K213264CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc.202114—
+3K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc.202015—
+4K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…Medtronic, Inc.20245—
+4K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc.20236—
+4K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)Biosense Webster, Inc.20220—
+5K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+5K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc.20235—
+6K252164NorthStar™ Mapping SystemImricor Medical Systems20261—
+6K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc.20252—
+6K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+6K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+6K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+7K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+7K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—
+7K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+7K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—