RETROFLEX DILATOR KIT

Dilator, Vessel, For Percutaneous Catheterization

EDWARDS LIFESCIENCES, LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Retroflex Dilator Kit.

Pre-market Notification Details

Device IDK093554
510k NumberK093554
Device Name:RETROFLEX DILATOR KIT
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
ContactJason K Lyon
CorrespondentJason K Lyon
EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-17
Decision Date2010-04-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690103192391 K093554 000

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