REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K063405) manufactured by Radiant Medical. 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 7, 2007. Regulation: 8.