PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET

PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET is an FDA 510(k)-cleared medical device (K874927) manufactured by Pioneering Technologies, 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 January 28, 1988. Regulation: 8.