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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 K140774
Device Name TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
Applicant
Terumo Cardiovascular Systems Corporation
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact EILEEN DORSEY
Correspondent
Terumo Cardiovascular Systems Corporation
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact EILEEN DORSEY
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTN   DTR  
Date Received03/28/2014
Decision Date 06/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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