510(k) Report

Devices descending from K110493

2 later devices reach Tandemheart Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.20191Class I
+2K232132LifeSPARC SystemCardiacassist, Inc.20230—