21 C.F.R. § 876.5010 Biliary catheter and accessories.
Title 21 - Food and Drugs
(a) Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices
§ 876.5010 Biliary catheter and accessories.
