FDA 510(k) Applications Submitted by MEDTRONIC INC

FDA 510(k) Number Submission Date Device Name Applicant
K191077 04/23/2019 Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor Medtronic Inc
K180453 02/20/2018 Bio-Medicus Adult Cannulae and Introducer Medtronic Inc
K160983 04/07/2016 Kyphon HV-R Bone Cement MEDTRONIC INC
K183511 12/18/2018 Affinity PixieÖ Oxygenator with BalanceÖ Biosurface (Model BBP211), Affinity PixieÖ Oxygenator and Cardiotomy/Venous Reservoir with BalanceÖ Biosurface (Model BBP241), Affinity PixieÖ Oxygenator with CortivaÖ BioActive Surface (Model CBP211), Affinity Pix Medtronic Inc
K183490 12/17/2018 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface Medtronic Inc


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