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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Patient Care
510(k) Number K160450
Device Name Pleurx Pleural Catheter System
Applicant
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact JOY GREIDANUS
Correspondent
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact TAMARA A. BREY
Regulation Number870.5050
Classification Product Code
DWM  
Date Received02/18/2016
Decision Date 10/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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