C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 876—GASTROENTEROLOGY-UROLOGY DEVICES › Subpart F—Therapeutic Devices

21 C.F.R. § 876.5010

Biliary catheter and accessories

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(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]
Notes of Decisions
Cited in 2 cases, 2011–2012 · leading case: United States Ex Rel. Nowak v. Medtronic, Inc.
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United States Ex Rel. Nowak v. Medtronic, Inc. (2011) mad · cites it 2× “” 21 C.F.R. § 876.5010 (a). Biliary stents are generally used to relieve the pain caused by bile blockages experienced by a limited number of late-stage cancer patients.”
United States ex rel. Colquitt v. Abbott Laboratories (2012) txnd “See 21 C.F.R. § 876.5010 . Patients with biliary cancer can develop cancerous growths that restrict the flow of bile through the bile ducts, so the stents are used to keep the bile ducts open, allowing bile to drain freely from the liver and gallbladder.”
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