LEADLINER CS LEAD DELIVERY SYSTEM

LEADLINER CS LEAD DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K133501) manufactured by Vascular Solutions, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2014. Regulation: 8.