AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Cp Centrifugal Blood Pump With Balance Biosurface.

Pre-market Notification Details

Device IDK111657
510k NumberK111657
Device Name:AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactLisa Stone
CorrespondentLisa Stone
MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2011-06-14
Decision Date2011-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994647850 K111657 000

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