AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Af100 Arterial Filter With Balance Biosurface.

Pre-market Notification Details

Device IDK122760
510k NumberK122760
Device Name:AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactJulia A Nelson
CorrespondentJulia A Nelson
MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-10
Decision Date2012-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169178124 K122760 000

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