SIGNATURE(TM) CUSTOM TUBING PACK

SIGNATURE(TM) CUSTOM TUBING PACK is an FDA 510(k)-cleared medical device (K924529) manufactured by Avecor 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 June 22, 1993. Regulation: 8.