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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 K092315
Device Name SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
Applicant
Sorin Group Italia S.R.L.
200 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SAIL
Correspondent
Sorin Group Italia S.R.L.
200 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SAIL
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Codes
DTP   JOD  
Date Received07/30/2009
Decision Date 08/12/2009
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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