TERUMO AL8X ARTERIAL FILTER WITH X-COATING

TERUMO AL8X ARTERIAL FILTER WITH X-COATING is an FDA 510(k)-cleared medical device (K032128) manufactured by Terumo Cardiovascular Systems Corp.. 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 31, 2003. Regulation: 8.