Edwards ESheath Introducer Set

Introducer, Catheter

Edwards Lifesciences

The following data is part of a premarket notification filed by Edwards Lifesciences with the FDA for Edwards Esheath Introducer Set.

Pre-market Notification Details

Device IDK200258
510k NumberK200258
Device Name:Edwards ESheath Introducer Set
ClassificationIntroducer, Catheter
Applicant Edwards Lifesciences 1 Edwards Way Irvine,  CA  92614
ContactVilma Arechiga
CorrespondentVilma Arechiga
Edwards Lifesciences 1 Edwards Way Irvine,  CA  92614
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-03-09

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