BARD STONE REMOVAL BALLOON CATHETER

BARD STONE REMOVAL BALLOON CATHETER is an FDA 510(k)-cleared medical device (K920342) manufactured by C.R. Bard, 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 August 25, 1992. Regulation: 8.