ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

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 Cvi1 Contrast Delivery System, Acist Cvi Contrast Delivery System.

Pre-market Notification Details

Device IDK203004
510k NumberK203004
Device Name:ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
ClassificationInjector And Syringe, Angiographic
Applicant ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie,  MN  55344
ContactJeff Koll
CorrespondentJeff Koll
ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie,  MN  55344
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-01
Decision Date2020-12-17

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