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e-CFR data is current as of April 16, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart F → §882.5225 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§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).