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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 K153140
Device Name Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
Applicant
Terumo Cardiovascular Systems Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact JOSHUA P. EWING
Correspondent
Terumo Cardiovascular Systems Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact JOSHUA P. EWING
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTN   DTP   DTR  
Date Received10/30/2015
Decision Date 12/02/2015
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
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