[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: 21CFR870.1200]

[Page 304]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 870--CARDIOVASCULAR DEVICES--Table of Contents
 
              Subpart B--Cardiovascular Diagnostic Devices
 
Sec. 870.1200  Diagnostic intravascular catheter.

    (a) Identification. An intravascular diagnostic catheter is a device 
used to record intracardiac pressures, to sample blood, and to introduce 
substances into the heart and vessels. Included in this generic device 
are right-heart catheters, left-heart catheters, and angiographic 
catheters, among others.
    (b) Classification. Class II (performance standards).