CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM

CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM is an FDA 510(k)-cleared medical device (K970392) 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 April 23, 1997. Regulation: 8.