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FDA 510(k) Applications Submitted by Sammie C Joseph-Fredericks
FDA 510(k) Number
Submission Date
Device Name
Applicant
K191029
04/18/2019
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« NT Int
Medtronic, Inc.
K201068
04/22/2020
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
Medtronic, Inc.
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