Tigereye ST O350
Tigereye ST O350 is a Class II device made by Avinger, Inc., cleared under FDA 510(k) K230594 on 25 Apr 2023 and listed in FDA GUDID since 24 Jul 2023 (UDI-DI 00851354004554), 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 | Number00851354004554 | Date24 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230594 | Date25 Apr 2023 | StatusActive |
Official records
- AccessGUDID record 00851354004554
- FDA 510(k) database K230594
Across registries
- FDA 510(k) K230594 decided 25 Apr 2023 Active
- FDA GUDID UDI-DI 00851354004554 listed 24 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K230594
- Listed FDA GUDID 00851354004554
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tigereye ST
- Generic name
- Atheroma crossing microdissection catheter, coronary
- Model / Ref / Catalog
- O350
- Primary DI / UDI-DI
- 00851354004554
- 510(k) Number
- FDA product code
- PDU, NQQ
- GMDN term
- Atheroma crossing microdissection catheter, coronary
- Device class
- Class II
- Regulation number
- 870.1250, 892.1560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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