510(k) Report

Devices descending from K052081

8 later devices reach Remote Access Perfusion (Rap) Femoral Venous Cannula through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250283RAP Femoral Venous CannulaeLivaNova USA, Inc.20250—
+1K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc.20066—
+2K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.20250—
+2K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech20091—
+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—