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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 K941225
Device Name UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
Applicant
Baxter Healthcare Corp
17511 Armstrong Ave.
P.O.Box 19522
Irvine,  CA  92713
Applicant Contact THOMAS J HUMPHREY
Correspondent
Baxter Healthcare Corp
17511 Armstrong Ave.
P.O.Box 19522
Irvine,  CA  92713
Correspondent Contact THOMAS J HUMPHREY
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/14/1994
Decision Date 08/16/1994
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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