AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE

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 Reservior With Balance Biosurface Model Bb841, Affinity Fusion Cardiotomy/ Venous Rese.

Pre-market Notification Details

Device IDK122914
510k NumberK122914
Device Name:AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-09-21
Decision Date2013-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169178144 K122914 000

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