ACIST PLUS 4 ANGIOGRAPHIC CATHETER

Catheter, Intravascular, Diagnostic

ACIST MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Acist Plus 4 Angiographic Catheter.

Pre-market Notification Details

Device IDK021015
510k NumberK021015
Device Name:ACIST PLUS 4 ANGIOGRAPHIC CATHETER
ClassificationCatheter, Intravascular, Diagnostic
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 CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-29
Decision Date2002-04-26
Summary:summary

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