LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON is an FDA 510(k)-cleared medical device (K911630) manufactured by Baxter Healthcare 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 26, 1991. Regulation: 8.