510(k) Report

Devices descending from DEN130045

11 later devices reach Heartflow Ffrct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262015Elucid FFR-IQ (B.1)Elucid Bioimaging, Inc.20260—
+1K152733FFRctHeartFlow, Inc.20169—
+2K161772FFRctHeartFlow, Inc.20168—
+3K213657Deepvessel FFRKeyamed Na, Inc.20220—
+3K182149FFRangio SystemCathworks, Ltd.20181—
+3K182035FFRctHeartFlow, Inc.20184—
+4K192442FFRangioCathworks, Ltd.20190—
+4K190925HeartFlow FFRct AnalysisHeartFlow, Inc.20193—
+5K203329HeartFlow AnalysisHeartFlow, Inc.20212—
+6K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+7K250902HeartFlow AnalysisHeartFlow, Inc.20250—