21 CFR 876.5010 - Biliary catheter and accessories.

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§ 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 (performance standards).

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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 876 after this date.

  • 2015-11-23; vol. 80 # 225 - Monday, November 23, 2015
    1. 80 FR 72899 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective November 23, 2015. The classification was applicable on April 27, 2012.
      21 CFR Part 876