COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD

COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD is an FDA 510(k)-cleared medical device (K982254) manufactured by Cobe Cardiovascular, 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 September 9, 1998. Regulation: 8.