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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 K926139
FOIA Releasable 510(k) K926139
Device Name CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH
Applicant
Bard Access Systems, Inc.
5425 W. Amelia Earnhart Dr.
Salt Lake City,  UT  84116
Applicant Contact JANE ANN MARTIN
Correspondent
Bard Access Systems, Inc.
5425 W. Amelia Earnhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact JANE ANN MARTIN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/07/1992
Decision Date 01/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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