INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET

INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET is an FDA 510(k)-cleared medical device (K001329) manufactured by Lifemed of California. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2001. Regulation: 8.