MODELS 5866-45 AND 5866-46 SIZING SLEEVE

MODELS 5866-45 AND 5866-46 SIZING SLEEVE is an FDA 510(k)-cleared medical device (K954085) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 6, 1995. Regulation: 8.