TERUMO PALL AL3X ARTERIAL FILTER

TERUMO PALL AL3X ARTERIAL FILTER is an FDA 510(k)-cleared medical device (K083747) 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 August 19, 2009. Regulation: 8.