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e-CFR data is current as of January 19, 2021

Title 21Chapter ISubchapter HPart 876Subpart F → §876.5010


Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices


§876.5010   Biliary catheter and accessories.

(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 (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]

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