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BD Intima II Closed IV Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K143610

by Becton Dickinson Infusion Therapy Systems Inc.

Identifiers

510(k) Number
K143610 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD Intima II Closed IV Catheter is a peripheral intravenous catheter designed for short-term vascular access. It is intended for monitoring blood pressure or administering intravenous fluids, featuring a closed-system configuration to reduce contamination risk during use.

This device is supplied sterile and intended for single-use in hospital settings, including general wards. It is classified under product code FOZ and has received FDA 510(k) clearance (K143610) as substantially equivalent to a predicate device. No MRI safety information or reusable variants are specified in the regulatory data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD INTIMA II CLOSED IV CATHETER (K143610) — FDA 510(k) | Innolitics, BD INTIMA II CLOSED IV CATHETER (K100775) — FDA 510(k) | Innolitics, Becton Dickinson – Wikipedia, BD Saf-T-Intima™ Safety System with BD Vialon™ Catheter Material and Y ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
FDA Applicant
Becton Dickinson Infusion Therapy Systems, Inc.

Sources (1)

  • FDA 510(k) K143610 24 fields · synced Sep 19, 2026