CXI Support Catheter

Catheter, Continuous Flush

COOK INCORPORATED

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cxi Support Catheter.

Pre-market Notification Details

Device IDK160884
510k NumberK160884
Device Name:CXI Support Catheter
ClassificationCatheter, Continuous Flush
Applicant COOK INCORPORATED 750 DANIELS WAY Bloomington,  IN  47404
ContactDaniel J. Corbin
CorrespondentDaniel J. Corbin
COOK INCORPORATED 750 DANIELS WAY Bloomington,  IN  47404
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-31
Decision Date2016-11-22
Summary:summary

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