ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)

ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) is an FDA 510(k)-cleared medical device (K980090) manufactured by Luther Medical Products, Inc.. 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 March 23, 1998. Regulation: 8.