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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Heart-Valve, Prosthesis
510(k) Number K871596
Device Name IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact RADINE POBUDA
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact RADINE POBUDA
Regulation Number870.3935
Classification Product Code
DTJ  
Date Received04/24/1987
Decision Date 06/15/1987
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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