MEDCOMP BIO-CATH CATHETER LINE

MEDCOMP BIO-CATH CATHETER LINE is an FDA 510(k)-cleared medical device (K003110) manufactured by Medcomp. 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 November 30, 2000. Regulation: 8.