Comaneci 17 ANPP7199
Comaneci 17 ANPP7199 is a Class II device made by Rapid Medical Ltd, granted FDA De Novo DEN170064 on 24 Apr 2019 and listed in FDA GUDID since 17 May 2019 (UDI-DI 07290015107150), active as of 12 Nov 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290015107150 | Date17 May 2019 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN170064 | Date24 Apr 2019 | StatusActive |
Official records
- AccessGUDID record 07290015107150
- FDA De Novo database DEN170064
Across registries
- FDA De Novo DEN170064 decided 24 Apr 2019 Active
- FDA GUDID UDI-DI 07290015107150 listed 17 May 2019 Listed
Timeline
- Granted FDA De Novo DEN170064
- Listed FDA GUDID 07290015107150
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- Comaneci 17
- Generic name
- Bare-metal intracranial vascular stent
- Model / reference
- ANPP7199
- Primary DI / UDI-DI
- 07290015107150
- De Novo Number
- FDA product code
- PUU
- GMDN term
- Bare-metal intracranial vascular stent
- Device class
- Class II
- Regulation number
- 882.5955
- GUDID distribution status
- In Commercial Distribution