The following data is part of a premarket notification filed by Devoro Medical, Inc. with the FDA for Wolf Thrombectomy System, 6f.
| Device ID | K210530 |
| 510k Number | K210530 |
| Device Name: | WOLF Thrombectomy System, 6F |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | DeVoro Medical, Inc. 46724 Lakeview Blvd Fremont, CA 94538 |
| Contact | Michael Wallace |
| Correspondent | Roberta Hines Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, WA 98077 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-24 |
| Decision Date | 2021-08-27 |