WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER

WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER is an FDA 510(k)-cleared medical device (K133615) manufactured by Well Lead Medical Co., Ltd.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2014. Regulation: 8.