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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 K191060
Device Name ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
Applicant
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  35344
Applicant Contact Matthew D. Stepanek
Correspondent
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  35344
Correspondent Contact Matthew D. Stepanek
Regulation Number870.1650
Classification Product Code
DXT  
Date Received04/22/2019
Decision Date 07/18/2019
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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