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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K122899
FOIA Releasable 510(k) K122899
Device Name POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
Applicant
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Applicant Contact AMY HONEY
Correspondent
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Correspondent Contact AMY HONEY
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/21/2012
Decision Date 11/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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