The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Ocelot System.
| Device ID | K122380 |
| 510k Number | K122380 |
| Device Name: | OCELOT SYSTEM |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | AVINGER, INC. 400 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Contact | Albert Boniske |
| Correspondent | Albert Boniske AVINGER, INC. 400 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2012-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851354004189 | K122380 | 000 |