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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K885221
Device Name MULTILUMEN CENTRAL VENOUS 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 Number870.1200
Classification Product Code
DQO  
Date Received12/20/1988
Decision Date 12/28/1989
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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