The following data is part of a premarket notification filed by Devoro Medical, Inc with the FDA for Wolf Thrombectomy™ Smartclaw Catheter.
| Device ID | K221391 |
| 510k Number | K221391 |
| Device Name: | WOLF Thrombectomy™ SmartClaw Catheter |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | DeVoro Medical, Inc 46724 Lakeview Blvd Fremont, CA 94358 |
| Contact | Vanessa Fowler |
| Correspondent | Vanessa Fowler DeVoro Medical, Inc 46724 Lakeview Blvd Fremont, CA 94358 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-11-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WOLF THROMBECTOMY 90734284 not registered Live/Pending |
Devoro Medical Inc. 2021-05-25 |