CYSTIC DUCT BALLOON DILATING CATHETER

CYSTIC DUCT BALLOON DILATING CATHETER is an FDA 510(k)-cleared medical device (K983154) manufactured by Applied Medical Resources. 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 May 4, 1999. Regulation: 8.