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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 K180950
Device Name Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
Applicant
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact Adam Pickholtz
Correspondent
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact Adam Pickholtz
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Code
DTN  
Date Received04/11/2018
Decision Date 06/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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