AVECOR PRE-BYPASS FILTER

AVECOR PRE-BYPASS FILTER is an FDA 510(k)-cleared medical device (K940126) 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 27, 1994. Regulation: 8.