XRES BLOOD COLLECTION RESERVOIR

XRES BLOOD COLLECTION RESERVOIR is an FDA 510(k)-cleared medical device (K100507) manufactured by Sorin Group Italia S.R.L.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2010. Regulation: 8.