Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Edwards Lifesciences LLC

The following data is part of a premarket notification filed by Edwards Lifesciences Llc with the FDA for Fem-flex Ii Femoral Arterial Cannula, Fem-flex Ii Femoral Venous Cannula, Femoral Venous Cannula, Femtrak Femoral Venous Cannula.

Pre-market Notification Details

Device IDK200358
510k NumberK200358
Device Name:Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant Edwards Lifesciences LLC One Edwards Way Irvine,  CA  92614
ContactAnna Califato
CorrespondentAnna Califato
Edwards Lifesciences LLC One Edwards Way Irvine,  CA  92614
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-13
Decision Date2020-03-13

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