Skip to content
De Novo DEN240023
- Device
- SmartFlow Neuro Cannula
- Contact
- brennan sullivan
- De Novo number
- DEN240023
- Product code
- SDG
- Regulation
- 882.4110
- Classification name
- brain intraparenchymal infusion cannula
- Decision
- granted (DENG)
- Decision date
- 2024-11-13
- Date received
- 2024-05-22
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- SDG
- Device name
- Brain Intraparenchymal Infusion Cannula
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.4110
- Implant
- N
- Life sustain/support
- N