Angled Tip Ureteral Catheter

Catheter, Urological

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Angled Tip Ureteral Catheter.

Pre-market Notification Details

Device IDK181144
510k NumberK181144
Device Name:Angled Tip Ureteral Catheter
ClassificationCatheter, Urological
Applicant Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
ContactChelsea Woods
CorrespondentChelsea Woods
Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-01
Decision Date2018-06-28
Summary:summary

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