Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K-Number: K203111 · 2021-09-16
ApplicantMedtronic
Decision Date2021-09-16
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2021-09-16 under approval number K203111. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System?
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System is a medical device that received FDA 510(k) clearance on 2021-09-16. It is manufactured by Medtronic. The 510(k) number is K203111.
When was Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System approved by the FDA?
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System received FDA 510(k) clearance on 2021-09-16, under approval number K203111.
What company makes Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System?
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System is manufactured by Medtronic.
What is the FDA product code for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System?
The FDA product code for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System is DTZ.
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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.