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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 K131103
Device Name XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
Applicant
Sorin Group Italia S.R.L.
14401 W. 65th Way
Arvada,  CO  80004
Applicant Contact SCOTT LIGHT
Correspondent
Sorin Group Italia S.R.L.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact SCOTT LIGHT
Regulation Number870.4400
Classification Product Code
DTN  
Date Received04/19/2013
Decision Date 06/06/2013
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
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