 |
Code of Federal Regulations (Last Updated: April 5, 2024) |
 |
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 |
§ 882.5225 - Implanted malleable clip.
Latest version.
-
§ 882.5225 Implanted malleable clip.
(a) Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed with a special instrument to occlude an intracranial blood vessel or aneurysm (a balloonlike sac formed on a blood vessel), stop bleeding, or hold tissue or a mechanical device in place in a patient.
(b) Classification. Class II (performance standards).