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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coronary Mechanical Thrombectomy With Aspiration
510(k) Number K253407
Device Name NeVa PV Thrombectomy Device
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
QEX  
Date Received09/30/2025
Decision Date 11/24/2025
Decision SE - With Limitations (SESU)
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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