PUMP, BYPASS, PULSATILE, AVCO

PUMP, BYPASS, PULSATILE, AVCO is an FDA 510(k)-cleared medical device (K770937) manufactured by Avco Medical Products. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 1977. Regulation: 8.