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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 K231239
Device Name Nexiva™ Closed IV Catheter System with NearPort™ IV Access
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  
Subsequent Product Code
FPA  
Date Received04/28/2023
Decision Date 09/22/2023
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
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