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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K252638
Device Name VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)
Applicant
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Applicant Contact Bobbie Daughters
Correspondent
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Correspondent Contact Bobbie Daughters
Regulation Number870.1650
Classification Product Code
DXT  
Date Received08/20/2025
Decision Date 05/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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