510(k) Report

Devices descending from K070240

58 later devices reach Carto XP EP Navigation System, Version 9 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc.2012312
+1K093566Carto XP EP Navigation System, Version 10Biosense Webster, Inc.201014—
+1K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+1K090017Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc.2009454
+2K201298VX1Volta Medical20208—
+2K152160Navik 3DApn Health, LLC201601
+2K133916Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc.2014272
+2K132782CARTO3 EP Navigation System, Version 3.2Biosense Webster, Inc.201441
+2K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+2K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+2K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc.2009341
+3K250749PhysCade SystemPhyscade, Inc.20250—
+3K233160NeuTrace EP Mapping System v.2.1Anumana, Inc.20230—
+3K232616Volta AF-XplorerVolta Medical20232—
+3K223516VX1+Volta Medical20234—
+3K220786STAR Apollo Mapping SystemRhythm Al, Ltd.20220—
+3K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+3K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+3K180940KODEX EPD SystemPhilips Medical Systems Nederland B.V.20181—
+3K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER ModuleBiosense Webster, Inc.20180—
+3K173837RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation20182—
+3K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleBiosense Webster, Inc.20180—
+3K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc.201720—
+3K162793RHYTHMIA HDx Mapping SystemBoston Scientific Corporation20173—
+3K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+3K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+3K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…Biosense Webster, Inc.2011331
+4K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+4K243812Volta AF-XplorerVolta Medical20251—
+4K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+4K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+4K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+4K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+4K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+4K212493KODEX – EPD™ System 1.5.0Philips Medical Systems Nederland, B.V. (Pmsn)20220—
+4K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—
+4K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc.201819—
+4K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc.2011322
+5K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+5K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+5K251518Volta AF-Xplorer IIVolta Medical20250—
+5K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc.2019161
+6K213264CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc.202114—
+6K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc.202015—
+7K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…Medtronic, Inc.20245—
+7K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc.20236—
+7K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)Biosense Webster, Inc.20220—
+8K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+8K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc.20235—
+9K252164NorthStar™ Mapping SystemImricor Medical Systems20261—
+9K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc.20252—
+9K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+9K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+9K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+10K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+10K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—
+10K252972CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.20260—
+10K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc.20260—