510(k) Report

Devices descending from K070902

7 later devices reach Modification to: Ensite System, Model, EE3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130750Rhythmia Mapping SystemRhythmia Medical, Inc.20134—
+1K083328Ensite System, Model EE3000, and Ensite Navx Surface Electrode, Model EN0010St Jude Medical20090—
+1K071818Ensite Fusion Dynamic Registration ToolSt Jude Medical20070—
+2K162793RHYTHMIA HDx Mapping SystemBoston Scientific Corporation20173—
+3K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+3K173837RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation20182—
+4K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—