The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console.
| Device ID | K140185 |
| 510k Number | K140185 |
| Device Name: | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | AVINGER, INC. 400 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Contact | Sherry Kim |
| Correspondent | Sherry Kim 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 | 2014-01-24 |
| Decision Date | 2014-05-01 |
| Summary: | summary |