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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K982467
Device Name CAPIOX CARDIOPLEGIA
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact SANDI HARTKA
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact SANDI HARTKA
Regulation Number870.4240
Classification Product Code
DTR  
Date Received07/15/1998
Decision Date 06/23/1999
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
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