Nanostim Introducer Kit

Introducer, Catheter

ST JUDE MEDICAL, INC.

The following data is part of a premarket notification filed by St Jude Medical, Inc. with the FDA for Nanostim Introducer Kit.

Pre-market Notification Details

Device IDK161102
510k NumberK161102
Device Name:Nanostim Introducer Kit
ClassificationIntroducer, Catheter
Applicant ST JUDE MEDICAL, INC. 15900 VALLEY VIEW CT Sylmar,  CA  91342
ContactHassan Labay
CorrespondentHassan Labay
ST. JUDE MEDICAL 645 ALMANOR AVENUE Sunnyvale,  CA  94085
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-19
Decision Date2016-05-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415067027535 K161102 000

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