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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K863697
Device Name MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact THOMAS, SCD
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact THOMAS, SCD
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received09/22/1986
Decision Date 10/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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