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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 K010390
Device Name ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
Applicant
Acist Medical Systems, Inc.
7450 Flying Clouds Dr.
Suite 150
Eden Prairie,  MN  55344
Applicant Contact CARL M BEAURLINE
Correspondent
Acist Medical Systems, Inc.
7450 Flying Clouds Dr.
Suite 150
Eden Prairie,  MN  55344
Correspondent Contact CARL M BEAURLINE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received02/09/2001
Decision Date 03/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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