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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K221391
Device Name WOLF Thrombectomy™ SmartClaw Catheter
Applicant
Devoro Medical, Inc.
46724 Lakeview Blvd.
Fremont,  CA  94358
Applicant Contact Vanessa Fowler
Correspondent
Devoro Medical, Inc.
46724 Lakeview Blvd.
Fremont,  CA  94358
Correspondent Contact Vanessa Fowler
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received05/13/2022
Decision Date 11/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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