Renal Access Cobra Catheter, Kumpe Access Catheter

Catheter, Urological

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Renal Access Cobra Catheter, Kumpe Access Catheter.

Pre-market Notification Details

Device IDK171600
510k NumberK171600
Device Name:Renal Access Cobra Catheter, Kumpe Access Catheter
ClassificationCatheter, Urological
Applicant Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
ContactSamuel Engelman
CorrespondentSamuel Engelman
Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-01
Decision Date2018-02-16
Summary:summary

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