MODIFICATION TO ACIST CL 100H

Injector And Syringe, Angiographic

ACIST MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Modification To Acist Cl 100h.

Pre-market Notification Details

Device IDK991103
510k NumberK991103
Device Name:MODIFICATION TO ACIST CL 100H
ClassificationInjector And Syringe, Angiographic
Applicant ACIST MEDICAL SYSTEMS 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie,  MN  55344
ContactCarl M Beaurline
CorrespondentCarl M Beaurline
ACIST MEDICAL SYSTEMS 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie,  MN  55344
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-01
Decision Date2000-05-31
Summary:summary

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