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510(k) K203111

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System by Medtronic — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2021
Date Received
October 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

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