BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE is an FDA 510(k)-cleared medical device (K131964) manufactured by Medtronic, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 23, 2013. Regulation: 8.