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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 K082117
Device Name QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
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  
Date Received07/28/2008
Decision Date 02/18/2009
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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