AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE

Oxygenator, 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 Or Balance Biosurface.

Pre-market Notification Details

Device IDK100645
510k NumberK100645
Device Name:AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactJessica Sixberry
CorrespondentJessica Sixberry
MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDTZ  
Subsequent Product CodeDTN
Subsequent Product CodeDTP
Subsequent Product CodeDTR
Subsequent Product CodeFLL
Subsequent Product CodeJOD
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-05
Decision Date2012-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994803177 K100645 000
20613994617310 K100645 000
20613994617303 K100645 000
20613994617273 K100645 000
20613994617259 K100645 000
20643169785803 K100645 000

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