510(k) Report

Devices descending from K002578

5 later devices reach Axillary Access Arterial Cannula through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032632Remote Access Perfusion Cannula Left Axillary 21 FrenchEstech, Inc.20034—
+2K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—