MODEL 5866-46 SLEEVE KIT

MODEL 5866-46 SLEEVE KIT is an FDA 510(k)-cleared medical device (K910568) manufactured by Medtronic Vascular. 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 8, 1991. Regulation: 8.