Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set

Catheter, Nephrostomy

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set.

Pre-market Notification Details

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Device IDK181735
510k NumberK181735
Device Name:Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
ClassificationCatheter, Nephrostomy
Applicant Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
ContactPaul Meyer
CorrespondentPaul Meyer
Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
Product CodeLJE  
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-02
Decision Date2019-03-27
Summary:summary

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