21 C.F.R. § 882.5225
Implanted malleable clip.
Cite as 21 C.F.R. § 882.5225 (2026)
(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).