HEART-CHILL SALINE SLUSH PAD

HEART-CHILL SALINE SLUSH PAD is an FDA 510(k)-cleared medical device (K882035) manufactured by Buckman Co., 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 July 27, 1988. Regulation: 8.