HBP · Clip, Implanted Malleable
Neurology · 21 CFR 882.5225 · Class 2
Overview
| Product Code | HBP |
|---|---|
| Device Name | Clip, Implanted Malleable |
| Regulation | 21 CFR 882.5225 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
