The following data is part of a premarket notification filed by Avinger, Inc with the FDA for Pantheris Catheter, Lightbix Hs Imaging Console, Lightbox Sled.
| Device ID | K162326 |
| 510k Number | K162326 |
| Device Name: | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Avinger, Inc 400 Chesapeake Drive Redwood City, CA 94063 |
| Contact | Patty Hevey |
| Correspondent | Patty Hevey Avinger, Inc 400 Chesapeake Drive Redwood City, CA 94063 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-19 |
| Decision Date | 2016-10-18 |
| Summary: | summary |