BARD HIGH FLOW PAPILLOTOME

BARD HIGH FLOW PAPILLOTOME is an FDA 510(k)-cleared medical device (K963484) manufactured by Bard Interventional Products Div.. 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 November 18, 1996. Regulation: 8.