510(k) Report

Devices descending from DEN200030

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214066FEops HEARTguideFeops NV20222—
+2K250635FEops HEARTguide Simulation ApplicationFeops NV20250—
+2K223809PrecisionTAVI (v1.1)Dasi Simulations20230—