510(k) Report

Devices descending from K214066

2 later devices reach FEops HEARTguide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250635FEops HEARTguide Simulation ApplicationFeops NV20250—
+1K223809PrecisionTAVI (v1.1)Dasi Simulations20230—