Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator With Plasma Resistant Fiber (PRF) With TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator With Plasma Resistant Fiber (Model 541), Affinity® N

Oxygenator, Cardiopulmonary Bypass

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Nttm Oxygenator (model 511), Affinity® Nt Hollow Fiber Oxygenator With Plasma Resistant Fiber (prf) With Trilliumtm Biosurface (model 511t), Affinity® Nt Integrated Cvr/membrane Oxygenator With Plasma Resistant Fiber (model 541), Affinity® N.

Pre-market Notification Details

Device IDK191029
510k NumberK191029
Device Name:Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator With Plasma Resistant Fiber (PRF) With TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator With Plasma Resistant Fiber (Model 541), Affinity® N
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Medtronic, Inc. 7611 Northland Drive Minneapolis,  MN  55428
ContactSammie C Joseph-fredericks
CorrespondentSammie C Joseph-fredericks
Medtronic, Inc. 7611 Northland Drive Minneapolis,  MN  55428
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-18
Decision Date2019-05-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20763000232126 K191029 000
20613994375623 K191029 000
20613994375630 K191029 000
20613994375654 K191029 000
20613994375678 K191029 000
20681490791100 K191029 000
20721902673331 K191029 000
20613994375647 K191029 000
20763000232140 K191029 000
20763000232089 K191029 000
20721902648896 K191029 000

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