Multi-Sideport Catheter Infusion Set

Catheter, Continuous Flush

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Multi-sideport Catheter Infusion Set.

Pre-market Notification Details

Device IDK182071
510k NumberK182071
Device Name:Multi-Sideport Catheter Infusion Set
ClassificationCatheter, Continuous Flush
Applicant Cook Incorporated P.O. Box 489, 750 Daniels Way Bloomington,  IN  47402
ContactReuben Lidster
CorrespondentReuben Lidster
Cook Incorporated P.O. Box 489, 750 Daniels Way Bloomington,  IN  47402
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-01
Decision Date2019-04-25

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