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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 K101153
Device Name QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
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 Code
DTR  
Date Received04/23/2010
Decision Date 12/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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