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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 K251312
Device Name Vesalio Peripheral System
Applicant
Vesalio, Inc.
2305 Historic Decatur Rd.
Suite 100
San Diego,  CA  92106
Applicant Contact Sharon Shachar
Correspondent
Vesalio, Inc.
2305 Historic Decatur Rd.
Suite 100
San Diego,  CA  92106
Correspondent Contact Sharon Shachar
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received04/28/2025
Decision Date 10/24/2025
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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