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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, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K192493
Device Name BD Cathena (TM) Safety IV Catheter
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Applicant Contact Henry Boland
Correspondent
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Correspondent Contact Henry Boland
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/11/2019
Decision Date 01/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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