The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Pantheris Catheter.
| Device ID | K160827 |
| 510k Number | K160827 |
| Device Name: | Pantheris Catheter |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | AVINGER, INC. 400 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Contact | Golnaz Moeini |
| Correspondent | Golnaz Moeini 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 | 2016-03-25 |
| Decision Date | 2016-04-21 |
| Summary: | summary |