21 CFR § 882.5225
Implanted malleable clip
June 25, 2020
(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).