ORIGEN DUAL LUMEN CATHETER

ORIGEN DUAL LUMEN CATHETER is an FDA 510(k)-cleared medical device (K003288) manufactured by Origen Biomedical, 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 June 7, 2001. Regulation: 8.