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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 K251372
Device Name VersaD Delivery Catheter
Applicant
Unity Medical, Inc.
6987 Washington Ave. S
Edina,  MN  55349
Applicant Contact Kim E. Aves
Correspondent
Unity Medical, Inc.
6987 Washington Ave. S
Edina,  MN  55439
Correspondent Contact Kim E. Aves
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received05/02/2025
Decision Date 10/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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