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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K251097
Device Name V-DAC Catheter
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 Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received04/10/2025
Decision Date 01/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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