510(k) Report

Devices descending from K133916

27 later devices reach Carto 3 EP Navigation System, Version 4.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233160NeuTrace EP Mapping System v.2.1Anumana, Inc.20230—
+1K180940KODEX EPD SystemPhilips Medical Systems Nederland B.V.20181—
+1K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER ModuleBiosense Webster, Inc.20180—
+1K173837RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation20182—
+1K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleBiosense Webster, Inc.20180—
+1K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc.201720—
+2K212493KODEX – EPD™ System 1.5.0Philips Medical Systems Nederland, B.V. (Pmsn)20220—
+2K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—
+2K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc.201819—
+3K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+3K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc.2019161
+4K213264CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc.202114—
+4K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc.202015—
+5K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…Medtronic, Inc.20245—
+5K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc.20236—
+5K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)Biosense Webster, Inc.20220—
+6K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+6K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc.20235—
+7K252164NorthStar™ Mapping SystemImricor Medical Systems20261—
+7K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc.20252—
+7K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+7K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+7K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+8K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+8K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—
+8K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+8K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—