Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K231239

Nexiva™ Closed IV Catheter System with NearPort™ IV Access

510(k) number
K231239
Device name
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
Applicant
Becton Dickinson Infusion Therapy Systems, Inc. UT · US
Product code
FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
Decision date
2023-09-22
Date received
2023-04-28
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K231239.pdf

Official FDA record: K231239
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.