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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 K122422
Device Name PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
Applicant
Care Fusion
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact JOY GREIDANUS
Correspondent
Care Fusion
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact JOY GREIDANUS
Regulation Number876.5630
Classification Product Code
PNG  
Date Received08/09/2012
Decision Date 10/24/2012
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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