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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K083794
Device Name MECC SET WITH BIOLINE COATING
Applicant
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Applicant Contact KATRIN SCHWENKGLENKS
Correspondent
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Correspondent Contact KATRIN SCHWENKGLENKS
Regulation Number870.4360
Classification Product Code
KFM  
Date Received12/22/2008
Decision Date 04/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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