510(k) Report

Devices descending from K093566

14 later devices reach Carto XP EP Navigation System, Version 10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201298VX1Volta Medical20208—
+1K132782CARTO3 EP Navigation System, Version 3.2Biosense Webster, Inc.201441
+2K250749PhysCade SystemPhyscade, Inc.20250—
+2K232616Volta AF-XplorerVolta Medical20232—
+2K223516VX1+Volta Medical20234—
+2K220786STAR Apollo Mapping SystemRhythm Al, Ltd.20220—
+2K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+2K162793RHYTHMIA HDx Mapping SystemBoston Scientific Corporation20173—
+3K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+3K243812Volta AF-XplorerVolta Medical20251—
+3K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+3K173837RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation20182—
+4K251518Volta AF-Xplorer IIVolta Medical20250—
+4K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—