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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K884322
Device Name SUBCLAVIAN HEMODIALYSIS CATHETER
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
9450 S. State Sreet
Sandy,  UT  84070
Applicant Contact CHARLES J WELLE
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
9450 S. State Sreet
Sandy,  UT  84070
Correspondent Contact CHARLES J WELLE
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received10/14/1988
Decision Date 04/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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