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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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