Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe

Catheter, Embolectomy

Edwards Lifesciences, LLC

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe.

Pre-market Notification Details

Device IDK193379
510k NumberK193379
Device Name:Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
ClassificationCatheter, Embolectomy
Applicant Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
ContactWendy Vera Gonzalez
CorrespondentWendy Vera Gonzalez
Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-05
Decision Date2020-06-12

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