510(k) Report

Devices descending from K080470

4 later devices reach Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32, Beq-RF-32 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+1K090515Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa)Maquet Cardiopulmonary, AG200901
+2K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+2K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—