EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE

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 Edwards Lifesciences Venous Return Cannulae.

Pre-market Notification Details

Device IDK092509
510k NumberK092509
Device Name:EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant EDWARDS LIFESCIENCES, LLC. 6864 SOUTH 300 WEST Midvale,  UT  84047
ContactKaren Jones
CorrespondentKaren Jones
EDWARDS LIFESCIENCES, LLC. 6864 SOUTH 300 WEST Midvale,  UT  84047
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-17
Decision Date2009-10-08
Summary:summary

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