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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 K922799
Device Name CAPIOX SX HOLLOW FIBER OXYGENATOR
Applicant
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Applicant Contact SANDI HARTKA
Correspondent
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Correspondent Contact SANDI HARTKA
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received06/10/1992
Decision Date 09/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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