Indigo System LITNGFHT100BER-D
Indigo System LITNGFHT100BER-D is a Class II device made by Penumbra, Inc., cleared under FDA 510(k) K241399 on 10 Jun 2024 and listed in FDA GUDID since 18 Jul 2024 (UDI-DI 00815948029842), active as of 22 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 | Number00815948029842 | Date18 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241399 | Date10 Jun 2024 | StatusActive |
Official records
- AccessGUDID record 00815948029842
- FDA 510(k) database K241399
Across registries
- FDA 510(k) K241399 decided 10 Jun 2024 Active
- FDA GUDID UDI-DI 00815948029842 listed 18 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K241399
- Listed FDA GUDID 00815948029842
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Indigo System
- Generic name
- Thrombectomy aspiration management software
- Model / reference
- LITNGFHT100BER-D
- Primary DI / UDI-DI
- 00815948029842
- 510(k) Number
- FDA product code
- QEW
- GMDN term
- Thrombectomy aspiration management software
- Device class
- Class II
- Regulation number
- 870.5150
- GUDID distribution status
- In Commercial Distribution
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