CATHETER WITH HARD VALVE

CATHETER WITH HARD VALVE is an FDA 510(k)-cleared medical device (K770489) manufactured by Pharmaseal Div., Baxter Healthcare Corp.. 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 March 20, 1977. Regulation: 8.