CARDIOGARD EMBOLI PROTECTION CANNULA

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

CARDIOGARD MEDICAL LTD

The following data is part of a premarket notification filed by Cardiogard Medical Ltd with the FDA for Cardiogard Emboli Protection Cannula.

Pre-market Notification Details

Device IDK141465
510k NumberK141465
Device Name:CARDIOGARD EMBOLI PROTECTION CANNULA
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant CARDIOGARD MEDICAL LTD 125 CHERRY LANE Armherst,  MA  01002
ContactSheila H Heyer
CorrespondentSheila H Heyer
CARDIOGARD MEDICAL LTD 125 CHERRY LANE Armherst,  MA  01002
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-03
Decision Date2015-01-09
Summary:summary

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