ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B

Injector And Syringe, Angiographic

INVASATEC

The following data is part of a premarket notification filed by Invasatec with the FDA for Angiographic Contrast Management System, Model Part A And Part B.

Pre-market Notification Details

Device IDK984231
510k NumberK984231
Device Name:ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
ClassificationInjector And Syringe, Angiographic
Applicant INVASATEC 7450 FLYING CLOUD DR. SUITE 150 Eden Prairie,  MN  55344
ContactKate Anderson
CorrespondentKate Anderson
INVASATEC 7450 FLYING CLOUD DR. SUITE 150 Eden Prairie,  MN  55344
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-25
Decision Date2000-05-31
Summary:summary

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