CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR882.5150]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 882 -- NEUROLOGICAL DEVICES

Subpart F - Neurological Therapeutic Devices

Sec. 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.

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