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BD INTROSYTE PRECISION INTRODUCER - Bd Introsyte Autoguard Shielded Introducer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020834

by Becton Dickinson Infusion Therapy Systems Inc.

Identifiers

510(k) Number
K020834 FDA 510(k)
FDA Product Code
DYB FDA 510(k)
Models / Variants
Bd Introsyte Precision Introducer FDA 510(k)
Bd Introsyte-N Precision Introducer FDA 510(k)
Bd Introsyte Autoguard Shielded Introducer FDA 510(k)
Bd I FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1340 FDA 510(k)
Regulation Number
870.1340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bd Introsyte Precision Introducer is a vascular access device designed to provide smooth and controlled entry into vessels for guidewire-assisted catheter placement. It is a sterile, single-use device. The introducer enables minimally invasive access, particularly for delicate or small vessels.

The device is supplied in various sizes, including 26 Gauge / 1.9 Fr. It is made of high density polyethylene and has a sheath inner diameter. The Bd Introsyte Precision Introducer has received FDA 510K authorization and is classified under product code DYB.

Frequently asked questions

What is the BD Introsyte Precision Introducer used for?

The BD Introsyte Precision Introducer is used for guidewire-assisted catheter placement, providing smooth and controlled entry into vessels, particularly for delicate or small vessels.

Is the BD Introsyte Precision Introducer sterile and single-use?

Yes, the BD Introsyte Precision Introducer is a sterile, single-use device, reducing the risk of infection and ensuring a safe procedure.

What sizes is the BD Introsyte Precision Introducer available in?

The BD Introsyte Precision Introducer is available in various sizes, including 26 Gauge / 1.9 Fr, to accommodate different patient needs and vessel sizes.

What material is the BD Introsyte Precision Introducer made of?

The BD Introsyte Precision Introducer is made of high density polyethylene, a durable and biocompatible material suitable for medical devices.

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 Introsyte-N™ Introducer (Conventional) - 384021 | BD, BD 384021 - Introsyte Introducer, 26 Gauge / 1.9 Fr Precision Vascular ..., BD Introsyte Autoguard™ Shielded Introducer 26G; 1.9Fr 10/CS | Needle ...

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) K020834 24 fields · synced Oct 6, 2026