Namic 70127404
Namic 70127404 is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K140194 on 14 Apr 2014 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI H965701274040), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberH965701274040 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140194 | Date14 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K140194
Across registries
- FDA 510(k) K140194 decided 14 Apr 2014 Active
- FDA GUDID UDI-DI H965701274040 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K140194
- Listed FDA GUDID H965701274040
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Namic
- Generic name
- Angiographic syringe
- Model / reference
- 70127404
- Primary DI / UDI-DI
- H965701274040
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- Angiographic syringe
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
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