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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(k) Number K173414
Device Name Advance Biliary Balloon Catheter
Applicant
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Colin Jacob
Correspondent
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Hui (Alice) Ouyang
Regulation Number876.5010
Classification Product Code
GCA  
Date Received11/01/2017
Decision Date 06/22/2018
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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