AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER

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 Or Without Coating, Affinity Cp Adapter.

Pre-market Notification Details

Device IDK132712
510k NumberK132712
Device Name:AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2013-08-29
Decision Date2013-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169855216 K132712 000
20763000134550 K132712 000
20763000134567 K132712 000
00763000301323 K132712 000
00643169272248 K132712 000
20643169433230 K132712 000
20643169433247 K132712 000
20643169433254 K132712 000
20643169785780 K132712 000
20763000074412 K132712 000
00643169272231 K132712 000
20643169855193 K132712 000
20643169855209 K132712 000
20763000134536 K132712 000

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