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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 K171646
Device Name ACISTCVi® Contrast Delivery System
Applicant
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Applicant Contact Melissa Sommerfeld
Correspondent
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Correspondent Contact Melissa Sommerfeld
Regulation Number870.1650
Classification Product Code
DXT  
Date Received06/05/2017
Decision Date 02/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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