510(k) Report

Devices descending from K202751

3 later devices reach TandemHeart Pump and Escort Controller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)20230—
+1K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)202311
+2K250199VitalFlow ConsoleMedtronic, Inc.202501