[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR870.1350]

[Page 293]
 
                        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. 870.1350  Catheter balloon repair kit.

    (a) Identification. A catheter balloon repair kit is a device used 
to repair or replace the balloon of a balloon catheter. The kit contains 
the materials, such as glue and balloons, necessary to effect the repair 
or replacement.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before December 26, 1996 for any catheter 
balloon repair kit that was in commercial distribution before May 28, 
1976, or that has, on or before December 26, 1996 been found to be 
substantially equivalent to a catheter balloon repair kit that was in 
commercial distribution before May 28, 1976. Any other catheter balloon 
repair kit shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 
61 FR 50706, Sept. 27, 1996]