510(k) DEN240023
- Device
- SmartFlow Neuro Cannula
- Applicant
- ClearPoint Neuro, Inc.
- 510(k) number
- DEN240023
- Product code
- SDG
- Decision
- Unknown (DENG)
- Decision date
- 2024-11-13
- Date received
- 2024-05-22
- Regulation
- 882.4110
- Classification name
- Brain Intraparenchymal Infusion Cannula
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Brennan Sullivan
- Address
- 120 S. Sierra Ave., Suite 100 Solana Beach CA US 92075 92075
FDA Registration Numbers#
- 3028006458
Source Documents#
510(k) summary PDF not indicated by FDA