PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE

PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE is an FDA 510(k)-cleared medical device (K874405) manufactured by Pall Biomedical Products Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 29, 1987. Regulation: 8.