The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Wildcat 7f Guidewire Support Catheter.
| Device ID | K083313 |
| 510k Number | K083313 |
| Device Name: | WILDCAT 7F GUIDEWIRE SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | AVINGER, INC. 400 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Contact | Himanshu Patel |
| Correspondent | Himanshu Patel AVINGER, INC. 400 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-02-02 |
| Summary: | summary |