KITAZATO IUI CATHETER

KITAZATO IUI CATHETER is an FDA 510(k)-cleared medical device (K131491) manufactured by Kitazato Medical Co., Ltd.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2013. Regulation: 8.