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510(k) K170336

Device
BD Nexiva Closed IV Catheter System (Single Port) With MaxZero Needleless Connector
Applicant
Becton, Dickinson And Company
510(k) number
K170336
Product code
FOZ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-03-10
Date received
2017-02-02
Regulation
880.5200
Classification name
Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Kimberly Geisler
Address
9450 S. State St. Sandy UT US 84070 84070

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FOZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261041ClearSafe Closed SystemMedSource Labs, LLC2026-07-10
K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC2026-07-09
K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.2026-05-15
K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2026-04-02
K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited2026-04-01
K252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.2025-12-17
K252677Polyshield Safety IV CathetersPoly Medicure Limited2025-11-05
K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-10-08
K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-07-25
K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-07-11
K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-06-27
K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc.2025-06-03
K243105Ruby Intravascular CatheterVenocare, Inc.2025-05-16
K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc.2025-05-02
K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)Access Vascular, Inc.2025-03-27

Legacy Summary#

summary

FDA Review#

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