AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811

Oxygenator, Cardiopulmonary Bypass

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Fusion Oxygenator With Integrated Arterial Filter And Balance Biosurface Model Bb811.

Pre-market Notification Details

Device IDK122827
510k NumberK122827
Device Name:AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactMary E Donlin
CorrespondentMary E Donlin
MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-14
Decision Date2012-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169178168 K122827 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.