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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 K253925
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 Received12/08/2025
Decision Date 01/15/2026
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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