Skip to contentDe Novo DEN140009
- Device
- AMIGO REMOTE CATHETER SYSTEM
- Contact
- jennifer englund
- De Novo number
- DEN140009
- Product code
- PJB
- Regulation
- 870.5700
- Classification name
- catheter remote control system
- Decision
- granted (DENG)
- Decision date
- 2014-12-18
- Date received
- 2014-02-18
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- PJB
- Device name
- Catheter Remote Control System
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.5700
- Implant
- N
- Life sustain/support
- N