Swan Ganz Catheters

Catheter, Flow Directed

Edwards Lifesciences, LLC

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Swan Ganz Catheters.

Pre-market Notification Details

Device IDK160084
510k NumberK160084
Device Name:Swan Ganz Catheters
ClassificationCatheter, Flow Directed
Applicant Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
ContactMugdha Dongre
CorrespondentMugdha Dongre
Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
Product CodeDYG  
Subsequent Product CodeDQE
Subsequent Product CodeDQO
Subsequent Product CodeKRA
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-15
Decision Date2016-05-03
Summary:summary

NIH GUDID Devices

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