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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, balloon, intra-aortic and control
510(k) Number K112372
Device Name CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
Original Applicant
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
1300 macarthur blvd.
mahwah,  NJ  07430
Original Contact helder a sousa
Regulation Number870.3535
Classification Product Code
DSP  
Date Received08/17/2011
Decision Date 09/15/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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