The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Tigereye Cto-crossing Catheter.
| Device ID | K212468 |
| 510k Number | K212468 |
| Device Name: | Tigereye CTO-Crossing Catheter |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-06 |
| Decision Date | 2022-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851354004509 | K212468 | 000 |