MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

EDWARDS LIFESCIENCES, LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Multi-med Central Venous Catheters (cvcs), With And Without Heparin Vantex Central Venous Catheters (cvcs), With Heparin.

Pre-market Notification Details

Device IDK113565
510k NumberK113565
Device Name:MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
ContactMargueite Thomlinson
CorrespondentMargueite Thomlinson
EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-02
Decision Date2012-05-18
Summary:summary

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