Relieva Tract RT1240AZ
Relieva Tract RT1240AZ is a Class I device made by Acclarent, Inc., cleared under FDA 510(k) K183090 on 19 Apr 2019 and listed in FDA GUDID since 31 May 2019 (UDI-DI 20705031462615), 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 | Number20705031462615 | Date31 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183090 | Date19 Apr 2019 | StatusActive |
Official records
- AccessGUDID record 20705031462615
- FDA 510(k) database K183090
Across registries
- FDA 510(k) K183090 decided 19 Apr 2019 Active
- FDA GUDID UDI-DI 20705031462615 listed 31 May 2019 Listed
Timeline
- Cleared FDA 510(k) K183090
- Listed FDA GUDID 20705031462615
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Relieva Tract
- Generic name
- Nasal/paranasal balloon catheter, non-tracking
- Model / Ref / Catalog
- RT1240AZ
- Primary DI / UDI-DI
- 20705031462615
- 510(k) Number
- FDA product code
- QGK
- GMDN term
- Nasal/paranasal balloon catheter, non-tracking
- Device class
- Class I
- Regulation number
- 874.4420
- GUDID distribution status
- In Commercial Distribution