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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
510(k) Number K160437
Device Name PleurX Peritoneal Catheter System
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 Number876.5630
Classification Product Code
PNG  
Date Received02/17/2016
Decision Date 11/03/2016
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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