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.