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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
Applicant
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
1300 MACARTHUR BLVD.
MAHWAH,  NJ  07430
Applicant Contact HELDER A SOUSA
Correspondent
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
1300 MACARTHUR BLVD.
MAHWAH,  NJ  07430
Correspondent 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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