[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: 21CFR870.1310]

[Page 304-305]
 
                        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

[[Page 305]]

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).