AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Affinity 20u Arterial Filter With Trillium Biosurface.

Pre-market Notification Details

Device IDK033468
510k NumberK033468
Device Name:AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
ContactMichele Pyfferoen
CorrespondentMichele Pyfferoen
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2003-11-03
Decision Date2003-11-14
Summary:summary

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