The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Pantheris Catheter (8fr), Pantheris Catheter (7fr).
| Device ID | K153460 |
| 510k Number | K153460 |
| Device Name: | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) |
| 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 | 2015-12-01 |
| Decision Date | 2016-03-01 |
| Summary: | summary |