Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)
K-Number: K183511 · 2019-03-18
Device Summary
Frequently Asked Questions
What is the Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)?
Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) is a medical device that received FDA 510(k) clearance on 2019-03-18. It is manufactured by Medtronic, Inc.. The 510(k) number is K183511.
When was Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) approved by the FDA?
Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) received FDA 510(k) clearance on 2019-03-18, under approval number K183511.
What company makes Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)?
Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) is manufactured by Medtronic, Inc..
What is the FDA product code for Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)?
The FDA product code for Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) is DTZ.
Related Clinical Trials
Other Devices by Medtronic, Inc.
Related Devices (Code: DTZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.