BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET

BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET is an FDA 510(k)-cleared medical device (K900186) manufactured by Shiley, 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 April 9, 1990. Regulation: 8.