The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Avinger Wildcat 6f Guidewire Support Catheter And Juicebox.
| Device ID | K111704 |
| 510k Number | K111704 |
| Device Name: | AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX |
| Classification | Catheter, Percutaneous |
| Applicant | AVINGER, INC. 400 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Contact | Sevrina Ciucci, Rac |
| Correspondent | Sevrina Ciucci, Rac 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 | 2011-06-17 |
| Decision Date | 2011-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851354004073 | K111704 | 000 |