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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K093986
Device Name AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
Applicant
Sorin Group Italia S.R.L.
195 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SALL
Correspondent
Sorin Group Italia S.R.L.
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number870.4260
Classification Product Code
DTM  
Date Received12/24/2009
Decision Date 01/22/2010
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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