MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM is an FDA 510(k)-cleared medical device (K983023) 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 September 30, 1998. Regulation: 8.