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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 K103191
Device Name QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
Applicant
MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN,  DE 72145
Applicant Contact KATRIN SCHWENKGLENKS
Correspondent
MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN,  DE 72145
Correspondent Contact KATRIN SCHWENKGLENKS
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTR  
Date Received10/28/2010
Decision Date 03/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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