Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump With Balance Biosurface, Affinity CP Centrifugal Blood Pump With Cortive BioActive Surface, Medtronic External Drive Motor

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, Affinity Cp Centrifugal Blood Pump With Balance Biosurface, Affinity Cp Centrifugal Blood Pump With Cortive Bioactive Surface, Medtronic External Drive Motor.

Pre-market Notification Details

Device IDK191077
510k NumberK191077
Device Name:Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump With Balance Biosurface, Affinity CP Centrifugal Blood Pump With Cortive BioActive Surface, Medtronic External Drive Motor
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant Medtronic Inc 7611 Northland Drive Minneapolis,  MN  55428
ContactHarsh Dharamshi
CorrespondentHarsh Dharamshi
Medtronic Inc 7611 Northland Drive Minneapolis,  MN  55428
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-23
Decision Date2019-08-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000244873 K191077 000
00763000244866 K191077 000

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