TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT

Reservoir, Blood, Cardiopulmonary Bypass

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Trillium Affinity Nt Cardiotomy Venous Reservoir, Models 540t, 541tt.

Pre-market Notification Details

Device IDK021287
510k NumberK021287
Device Name:TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
ContactPreeti Jain
CorrespondentPreeti Jain
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-23
Decision Date2002-05-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20721902648759 K021287 000

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