510(k) Report

Devices descending from K913176

4 later devices reach Delphin II Centrifugal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+2K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+3K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—