Black Silicone Filiform Double Pigtail Stent Set

Stent, Ureteral

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Black Silicone Filiform Double Pigtail Stent Set.

Pre-market Notification Details

Device IDK172017
510k NumberK172017
Device Name:Black Silicone Filiform Double Pigtail Stent Set
ClassificationStent, Ureteral
Applicant Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington,  IN  47402
ContactKarthik Pillai
CorrespondentKarthik Pillai
Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington,  IN  47402
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-03
Decision Date2018-03-26
Summary:summary

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