[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4200]

[Page 374]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 878.4200  Introduction/drainage catheter and accessories.

    (a) Identification. An introduction/drainage catheter is a device 
that is a flexible single or multilumen tube intended to be used to 
introduce nondrug fluids into body cavities other than blood vessels, 
drain fluids from body cavities, or evaluate certain physiologic 
conditions. Examples include irrigation and drainage catheters, 
pediatric catheters, peritoneal catheters (including dialysis), and 
other general surgical catheters. An introduction/drainage catheter 
accessory is intended to aid in the manipulation of or insertion of the 
device into the body. Examples of accessories include adaptors, 
connectors, and catheter needles.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]