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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Catheter
510(k) Number K874618
Device Name BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER
Applicant
Bentley Laboratories, Inc.
17502 Armstrong Ave.
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact MERRITT GIRGIS
Correspondent
Bentley Laboratories, Inc.
17502 Armstrong Ave.
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact MERRITT GIRGIS
Regulation Number870.1300
Classification Product Code
DQR  
Date Received11/09/1987
Decision Date 01/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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