510(k) Report

Devices descending from K061369

4 later devices reach Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+1K073631Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation20080—
+2K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+2K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—