AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T

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 38 Micon Arterial Filter With Trillium Biopassive Surface, Model 351t.

Pre-market Notification Details

Device IDK013084
510k NumberK013084
Device Name:AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
ContactMarie Holm
CorrespondentMarie Holm
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-14
Decision Date2001-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20721902363591 K013084 000

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