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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Peritoneal
510(k) Number K170405
Device Name BD Curve Ascites Shunt
Applicant
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Tamara Brey
Correspondent
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Tamara Brey
Regulation Number876.5955
Classification Product Code
KPM  
Subsequent Product Code
DYB  
Date Received02/10/2017
Decision Date 11/02/2017
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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