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510(k) K151389

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir by Terumo Cardiovascular Systems Corporation — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2015
Date Received
May 26, 2015
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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