The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Pantheris System.
| Device ID | K152275 |
| 510k Number | K152275 |
| Device Name: | Pantheris System |
| 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 | 2015-08-12 |
| Decision Date | 2015-10-14 |
| Summary: | summary |