ULTRASKIN HYDROPHILIC GUIDE WIRE

ULTRASKIN HYDROPHILIC GUIDE WIRE is an FDA 510(k)-cleared medical device (K141707) 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 January 20, 2015. Regulation: 8.