K-number	K203111
Device name	Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
Applicant	Medtronic
Product code	DTZ
Device class	Class II
Decision date	Sep 16, 2021
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

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