[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: 21CFR870.1310]

[Page 297]
 
                        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. 870.1310  Vessel dilator for percutaneous catheterization.

    (a) Identification. A vessel dilator for percutaneous 
catheterization is a device which is placed over the guide wire to 
enlarge the opening in the vessel, and which is then removed before 
sliding the catheter over the guide wire.
    (b) Classification. Class II (performance standards).