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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 K110396
Device Name ASPIRA PERITONEAL DRAINAGE SYSTEM
Applicant
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Applicant Contact HENRY BOLAND
Correspondent
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Correspondent Contact HENRY BOLAND
Regulation Number876.5630
Classification Product Code
PNG  
Date Received02/11/2011
Decision Date 05/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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