21 CFR 882.5225 — Clip, Implanted Malleable
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5225
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HBP | Clip, Implanted Malleable | 2 | 0 | Implant |
