De Novo DEN150040
- Device
- WallFlex Biliary RX Fully Covered Stent System RMV
- Contact
- thomas hirte
- De Novo number
- DEN150040
- Product code
- PNB
- Regulation
- 876.5011
- Classification name
- biliary stent system for benign strictures
- Decision
- granted (DENG)
- Decision date
- 2016-06-03
- Date received
- 2015-08-28
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- PNB
- Device name
- Biliary Stent System For Benign Strictures
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5011
- Implant
- Y
- Life sustain/support
- N