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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 K040298
Device Name ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
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 Received02/09/2004
Decision Date 03/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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