Ocelot III O200
Ocelot III O200 is a Class II device made by Avinger, Inc., cleared under FDA 510(k) K122380 on 7 Nov 2012 and listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00851354004189), 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 | Number00851354004189 | Date21 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122380 | Date7 Nov 2012 | StatusActive |
Official records
- AccessGUDID record 00851354004189
- FDA 510(k) database K122380
Across registries
- FDA 510(k) K122380 decided 7 Nov 2012 Active
- FDA GUDID UDI-DI 00851354004189 listed 21 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K122380
- Listed FDA GUDID 00851354004189
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ocelot III
- Generic name
- Mechanical atherectomy system, coronary/peripheral
- Model / Ref / Catalog
- O200
- Primary DI / UDI-DI
- 00851354004189
- 510(k) Number
- FDA product code
- NQQ, DQY
- GMDN term
- Mechanical atherectomy system, coronary/peripheral
- Device class
- Class II
- Regulation number
- 892.1560, 870.1250
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
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