ASI HEMOSTASIS CATHETER

ASI HEMOSTASIS CATHETER is an FDA 510(k)-cleared medical device (K901336) manufactured by Advanced Surgical Intervention, Inc.. 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 June 19, 1990. Regulation: 8.