De Novo DEN240048
- Device
- Spur Peripheral Retrievable Stent System
- Contact
- lori grace
- De Novo number
- DEN240048
- Product code
- SEU
- Regulation
- 870.5110
- Classification name
- peripheral temporary and retrievable stent system
- Decision
- granted (DENG)
- Decision date
- 2025-05-29
- Date received
- 2024-09-20
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- SEU
- Device name
- Peripheral Temporary And Retrievable Stent System
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.5110
- Implant
- N
- Life sustain/support
- N