The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Pantheris Catheter (8f), Pantheris Catheter (7f), Lightbox Hs Imaging Console, Lightbox Sled.
| Device ID | K172236 |
| 510k Number | K172236 |
| Device Name: | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-25 |
| Decision Date | 2017-10-30 |
| Summary: | summary |