DENVER(R) PERITONEO-SUBCLAVIAN SHUNT

DENVER(R) PERITONEO-SUBCLAVIAN SHUNT is an FDA 510(k)-cleared medical device (K913728) manufactured by Denver Biomedicals, 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 February 17, 1994. Regulation: 8.