510(k) Report

Devices descending from K191660

16 later devices reach CARTO 3 EP Navigation System, Version 7.1 and Accessories through their predicates, nearest generation first.

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