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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 K934763
Device Name SORIN BLOOD CARDIOPLEGIA SYSTEM
Applicant
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92713
Applicant Contact TERRY SCHULTZ
Correspondent
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92713
Correspondent Contact TERRY SCHULTZ
Regulation Number870.4400
Classification Product Code
DTN  
Date Received10/05/1993
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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