AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE

Reservoir, Blood, Cardiopulmonary Bypass

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Pixie Oxygenation System With; Carmeda Bioactive Surface, Balance Biosuface.

Pre-market Notification Details

Device IDK141233
510k NumberK141233
Device Name:AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactJessica Sixberry
CorrespondentJessica Sixberry
MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDTN  
Subsequent Product CodeDTP
Subsequent Product CodeJOD
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-13
Decision Date2014-06-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169785827 K141233 000

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