EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL

Introducer, Catheter

EDWARDS LIFESCIENCES, LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Lifesciences Percutaneous Sheath Introducers With Oligon Material.

Pre-market Notification Details

Device IDK014052
510k NumberK014052
Device Name:EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
ClassificationIntroducer, Catheter
Applicant EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
ContactJason Smith
CorrespondentJason Smith
EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-10
Decision Date2002-03-08
Summary:summary

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