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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 K921845
Device Name INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT
Applicant
Becton Dickinson Vascular Access, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact C. J WELLE
Correspondent
Becton Dickinson Vascular Access, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact C. J WELLE
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/17/1992
Decision Date 11/10/1992
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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