Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 882  /  Sec. 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).