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510(k) K200109

OXY-1 System by Abiomed, Inc. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2020
Date Received
January 17, 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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