21 CFR §882.5225
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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).