21 C.F.R. § 882.5225

Implanted malleable clip.

Last amended: 2016Year: 2026Length: 56 wordsSubsections: 2Official source

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).
21 C.F.R. § 882.5225: Implanted malleable clip. | Justis AI