510(k) Report

Devices descending from K161772

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

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