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 |