CERENOVUS Large Bore Catheter

CERENOVUS Large Bore Catheter is an FDA 510(k)-cleared medical device (K191237) manufactured by Codman & Shurtleff, 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 November 7, 2019. Regulation: 8.