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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K132166
Device Name VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
Applicant
Maquet Cardiopulmonary, AG
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Applicant Contact INGRID RICHTER
Correspondent
Maquet Cardiopulmonary, AG
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Correspondent Contact INGRID RICHTER
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Codes
DTP   JOD  
Date Received07/12/2013
Decision Date 10/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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