SDG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Brain Intraparenchymal Infusion Cannula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4110
- Medical specialty
- Neurology
- FDA definition
- A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy.
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| Record | Firm | Date |
|---|---|---|
| SmartFlow Neuro Cannula (DEN240023) | ClearPoint Neuro, Inc. | 2024-11-13 |
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