Ocelot Catheter
510(k) K123462
Ocelot Catheter is a Class II device made by Avinger, Inc., cleared under FDA 510(k) K123462 on 7 Dec 2012, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123462 | Date7 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K123462
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PDU
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K123462
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Ocelot IV O250 | O250 / O250 | 00851354004233 | — | On the market |
Similar devices
Other devices filed under FDA product code PDU (Catheter For Crossing Total Occlusions).
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- THE CROSSER SYSTEM by Flowcardia, Inc.
- PIONEER PLUS CATHETER by MEDTRONIC, INC.
- OUTBACK Elite Re-Entry Catheter by Cordis Corp., A Johnson & Johnson Co.
- MICRO GUIDE CATHETER XP by Cordis US Corp.
- RVT CTO DEVICE by Revascular Therapeutics, Inc.