[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: 21CFR870.1220]

[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. 870.1220  Electrode recording catheter or electrode recording probe.

    (a) Identification. An electrode recording catheter or an electrode 
recording probe is a device used to detect an intracardiac 
electrocardiogram, or to detect cardiac output or left-to-right heart 
shunts. The device may be unipolar or multipolar for electrocardiogram 
detection, or may be a platinum-tipped catheter which senses the 
presence of a special indicator for cardiac output or left-to-right 
heart shunt determinations.
    (b) Classification. Class II (performance standards).