UPJ Occlusion Balloon Catheter

Catheter, Ureteral, Gastro-urology

COOK Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Upj Occlusion Balloon Catheter.

Pre-market Notification Details

Device IDK183323
510k NumberK183323
Device Name:UPJ Occlusion Balloon Catheter
ClassificationCatheter, Ureteral, Gastro-urology
Applicant COOK Incorporated 750 Daniels Way Bloomington,  IN  47404
ContactJohnathan Liu
CorrespondentJohnathan Liu
COOK Incorporated 750 Daniels Way Bloomington,  IN  47404
Product CodeEYB  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-30
Decision Date2019-08-05

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