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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filter, blood, cardiopulmonary bypass, arterial line
510(k) Number K061546
Device Name QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
Original Applicant
MAQUET CARDIOPULMONARY AG
hechinger strasse 38
hirrlingen,  GM 72145
Original Contact katrin schwenkglenks
Regulation Number870.4260
Classification Product Code
DTM  
Date Received06/05/2006
Decision Date 06/20/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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