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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K262030
Device Name Aventus Thrombectomy System
Applicant
Inquis Medical
1530 O'Brien Dr.
Suite A
Menlo Park,  CA  94025
Applicant Contact Zachary Woodson
Correspondent
Inquis Medical
1530 O'Brien Dr.
Suite A
Menlo Park,  CA  94025
Correspondent Contact Zachary Woodson
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Codes
CAC   KRA  
Date Received06/17/2026
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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