510(k) Report

Devices descending from K140497

8 later devices reach Ecvue Mapping System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150990ECVUE Mapping SystemCardioinsight Technologies, Inc.20157—
+2K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.20166—
+3K253861Acorys Mapping SystemCorify Care S.L20260—
+3K183195VIVOCatheter Precision, Inc.20191—
+3K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc.20182—
+4K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+4K200313VIVOCatheter Precision, Inc.20200—
+5K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—