The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Wildcat 6f Guidewire Support Catheter Model W400l And W400s.
| Device ID | K102022 |
| 510k Number | K102022 |
| Device Name: | WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S |
| 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 | 2010-07-19 |
| Decision Date | 2010-08-06 |
| Summary: | summary |