CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL

CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL is an FDA 510(k)-cleared medical device (K913801) manufactured by Cordis Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 1991. Regulation: 8.