ARROW HANDS-OFF THERMO-PACE

ARROW HANDS-OFF THERMO-PACE is an FDA 510(k)-cleared medical device (K895268) manufactured by Arrow Intl., 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 5, 1989. Regulation: 8.