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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K254211
Device Name pVasc Net Mechanical 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
Date Received12/29/2025
Decision Date 08/05/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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