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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 K910107
Device Name DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
Applicant
Baxter Healthcare Corp
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact DONALD A RAIBLE
Correspondent
Baxter Healthcare Corp
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact DONALD A RAIBLE
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received01/10/1991
Decision Date 04/10/1991
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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