510(k) Report

Devices descending from K090017

45 later devices reach Carto 3 EP Navigation System, V1.0 and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093566Carto XP EP Navigation System, Version 10Biosense Webster, Inc.201014—
+1K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc.2009341
+2K201298VX1Volta Medical20208—
+2K132782CARTO3 EP Navigation System, Version 3.2Biosense Webster, Inc.201441
+2K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…Biosense Webster, Inc.2011331
+3K250749PhysCade SystemPhyscade, Inc.20250—
+3K232616Volta AF-XplorerVolta Medical20232—
+3K223516VX1+Volta Medical20234—
+3K220786STAR Apollo Mapping SystemRhythm Al, Ltd.20220—
+3K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+3K162793RHYTHMIA HDx Mapping SystemBoston Scientific Corporation20173—
+3K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc.2011322
+4K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+4K243812Volta AF-XplorerVolta Medical20251—
+4K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+4K173837RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation20182—
+4K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc.2012312
+5K251518Volta AF-Xplorer IIVolta Medical20250—
+5K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—
+5K152160Navik 3DApn Health, LLC201601
+5K133916Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc.2014272
+6K233160NeuTrace EP Mapping System v.2.1Anumana, Inc.20230—
+6K180940KODEX EPD SystemPhilips Medical Systems Nederland B.V.20181—
+6K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER ModuleBiosense Webster, Inc.20180—
+6K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleBiosense Webster, Inc.20180—
+6K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc.201720—
+7K212493KODEX – EPD™ System 1.5.0Philips Medical Systems Nederland, B.V. (Pmsn)20220—
+7K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc.201819—
+8K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc.2019161
+9K213264CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc.202114—
+9K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc.202015—
+10K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…Medtronic, Inc.20245—
+10K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc.20236—
+10K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)Biosense Webster, Inc.20220—
+11K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+11K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc.20235—
+12K252164NorthStar™ Mapping SystemImricor Medical Systems20261—
+12K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc.20252—
+12K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+12K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+12K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+13K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+13K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—
+13K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+13K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—