FDA 510(k) Applications Submitted by Tyler Senjem

FDA 510(k) Number Submission Date Device Name Applicant
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


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