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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 K161777
Device Name BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
Becton Dickinson Infusion Therapy Systems, Inc.
9450 South State Street
Sandy,  UT  84070
Applicant Contact Kimberly Geisler
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5200
Classification Product Code
Date Received06/29/2016
Decision Date 08/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls