200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER

200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER is an FDA 510(k)-cleared medical device (K132905) manufactured by Arteriocyte Medical Systems, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 2013. Regulation: 8.