SHOOCIN INTRODUCER KIT

SHOOCIN INTRODUCER KIT is an FDA 510(k)-cleared medical device (K123475) manufactured by Lepu Medical Technology (Beijing) Co., Ltd.. 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 2, 2014. Regulation: 8.