Surefire Infusion System 021

Surefire Infusion System 021 is an FDA 510(k)-cleared medical device (K143588) manufactured by Surefire Medical, 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 11, 2015. Regulation: 8.