AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE

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 Bllod Pump With Carmeda Bioactive Surface.

Pre-market Notification Details

Device IDK111658
510k NumberK111658
Device Name:AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant MEDTRONIC INC. 8200 CORAL SEA ST NE Mounds View,  MN  55112
ContactLisa Stone
CorrespondentLisa Stone
MEDTRONIC INC. 8200 CORAL SEA ST 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 Date2011-06-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994647867 K111658 000

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