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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K140569
Device Name ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
Applicant
Maquet Cardiopulmonary, AG
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Applicant Contact SARAH BETZ
Correspondent
Maquet Cardiopulmonary, AG
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Correspondent Contact SARAH BETZ
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/06/2014
Decision Date 11/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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