510(k) Report

Devices descending from K060101

6 later devices reach Estech Aortic Easy Flow Cannula through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.20250—
+1K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech20091—
+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—