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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K151791
Device Name Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
Applicant
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact JAIME LEE
Correspondent
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact JAIME LEE
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTN   DTR  
Date Received07/01/2015
Decision Date 11/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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