AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE

Reservoir, Blood, Cardiopulmonary Bypass

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Fusion Cardiotomy/venous Reservoir With Balance Biosurface.

Pre-market Notification Details

Device IDK132972
510k NumberK132972
Device Name:AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactJulia A Nelson
CorrespondentJulia A Nelson
MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-23
Decision Date2013-10-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169354876 K132972 000
00643169354869 K132972 000

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