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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K133598
FOIA Releasable 510(k) K133598
Device Name CARDIOHELP SYSTEM
Applicant
MAQUET CARDIOPULMONARY AG
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact HELDER A SOUSA
Correspondent
MAQUET CARDIOPULMONARY AG
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact HELDER A SOUSA
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received11/22/2013
Decision Date 05/21/2014
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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