510(k) Report

Devices descending from K132782

4 later devices reach CARTO3 EP Navigation System, Version 3.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162793RHYTHMIA HDx Mapping SystemBoston Scientific Corporation20173—
+2K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+2K173837RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation20182—
+3K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—