The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Wildcat 5f Guidewire Support Catheter, Mode W500.
| Device ID | K101647 |
| 510k Number | K101647 |
| Device Name: | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-11 |
| Decision Date | 2010-08-06 |
| Summary: | summary |