21 C.F.R. § 882.5225

Current through October 31, 2024
Section 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).

21 C.F.R. §882.5225