ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS

Injector And Syringe, Angiographic

ACIST MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Angiographic Injection System, Model R2000-cms.

Pre-market Notification Details

Device IDK010390
510k NumberK010390
Device Name:ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
ClassificationInjector And Syringe, Angiographic
Applicant ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie,  MN  55344
ContactCarl M Beaurline
CorrespondentCarl M Beaurline
ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie,  MN  55344
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-09
Decision Date2001-03-09

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