CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART F—Neurological Therapeutic Devices (§882.5030 to §882.5975) > 882.5150—Intravascular occluding catheter.

882.5150—Intravascular occluding catheter.

(a) Identification. An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or a 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 intravascular occluding catheter 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 an intravascular occluding catheter that was in commercial distribution before May 28, 1976. Any other intravascular occluding catheter shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Code of Federal Regulations

[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996]