The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Pantheris Catheter (8f); Pantheris Cather (7f); Lightbox Hs Imaging Console; Lightbox Sled.
| Device ID | K163264 |
| 510k Number | K163264 |
| Device Name: | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2016-12-21 |
| Summary: | summary |