WallFlex Biliary RX Fully Covered Stent System RMV
De Novo DEN150040
Active
De Novo
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN150040 | Date3 Jun 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 9 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA product code
- PNB
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5011
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- DENG De Novo granted