510(k) Report

Devices descending from K152733

9 later devices reach FFRct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161772FFRctHeartFlow, Inc.20168—
+2K213657Deepvessel FFRKeyamed Na, Inc.20220—
+2K182149FFRangio SystemCathworks, Ltd.20181—
+2K182035FFRctHeartFlow, Inc.20184—
+3K192442FFRangioCathworks, Ltd.20190—
+3K190925HeartFlow FFRct AnalysisHeartFlow, Inc.20193—
+4K203329HeartFlow AnalysisHeartFlow, Inc.20212—
+5K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+6K250902HeartFlow AnalysisHeartFlow, Inc.20250—