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FDA 510(k)

Nexiva™ Closed IV Catheter System with NearPort™ IV Access

K-Number: K231239 · 2023-09-22

ApplicantBecton Dickinson Infusion Therapy Systems, Inc.
Decision Date2023-09-22
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nexiva™ Closed IV Catheter System with NearPort™ IV Access is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231239. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nexiva™ Closed IV Catheter System with NearPort™ IV Access?

Nexiva™ Closed IV Catheter System with NearPort™ IV Access is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K231239.

When did Nexiva™ Closed IV Catheter System with NearPort™ IV Access receive FDA 510(k) clearance?

Nexiva™ Closed IV Catheter System with NearPort™ IV Access received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231239.

Who is the listed applicant for Nexiva™ Closed IV Catheter System with NearPort™ IV Access?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexiva™ Closed IV Catheter System with NearPort™ IV Access?

The FDA product code for Nexiva™ Closed IV Catheter System with NearPort™ IV Access is FOZ.

Other records listing Becton Dickinson Infusion Therapy Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252137BD Insyte™ IV CatheterK251422BD Saf-T-Intima™ Subcutaneous Catheter SystemK243403BD Nexiva™ Closed IV Catheter SystemK251155BD Cathena™ Safety IV CatheterK251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterK250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

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Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.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 Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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