Implanted malleable clip.

21 C.F.R. § 882.5225
in effectEffective: 2024-07-01
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(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).

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