[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5010]

[Page 366]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                     Subpart F--Therapeutic Devices
 
Sec. 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).