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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 K220584
Device Name BD Cathena Safety IV Catheter
Applicant
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy,  UT  84070
Applicant Contact Paul Holman
Correspondent
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy,  UT  84070
Correspondent Contact Paul Holman
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/01/2022
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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