EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM

Stent, Ureteral

BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Expel Nephroureteral Drainage Stent With Twist-loc Hub System, Expel Ureteral Drainage Stent System.

Pre-market Notification Details

Device IDK141344
510k NumberK141344
Device Name:EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
ClassificationStent, Ureteral
Applicant BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactMatt Beauchane
CorrespondentMatt Beauchane
BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-22
Decision Date2014-10-17
Summary:summary

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