DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY is an FDA 510(k)-cleared medical device (K101497) manufactured by Oscor, 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 October 19, 2010. Regulation: 8.