MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH

MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH is an FDA 510(k)-cleared medical device (K930623) manufactured by Boston Scientific Corp. 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 September 27, 1994. Regulation: 8.