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Modification to Nitrex Nitinol Guidewire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040345

by Ev3, Inc

Identifiers

510(k) Number
K040345 FDA 510(k)
FDA Product Code
DQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a modification to the Nitrex Nitinol guidewire, classified as a Wire, Guide, Catheter under product code DQX. It features a nitinol (nickel-titanium alloy) construction with a distal tip incorporating a helically coiled gold-plated tungsten wire and a surface coating.

It is supplied as a sterile, single-use device intended for cardiovascular applications. The device received FDA 510(k) clearance (K040345) on March 2, 2004, as substantially equivalent to a predicate device, and is subject to special controls under Class II regulation.

Frequently asked questions

What is the Modification to Nitrex Nitinol Guidewire used for?

This device is intended for cardiovascular applications as a guidewire to facilitate catheter placement, leveraging its nitinol construction and specialized distal tip for navigation within vascular pathways.

How is the Modification to Nitrex Nitinol Guidewire supplied and is it reusable?

The device is supplied sterile and designed for single-use only; it must not be reprocessed or reused due to risks of material degradation, coating compromise, and potential contamination after initial use.

What materials and design features define the Modification to Nitrex Nitinol Guidewire?

It is constructed from nitinol (nickel-titanium alloy) with a distal tip incorporating a helically coiled gold-plated tungsten wire and a surface coating, enhancing flexibility, torque response, and radiopacity during cardiovascular procedures.

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: K040345 FDA 510(k) - MODIFICATION TO NITREX NITINOL GUIDEWIRE, Modification to Nitrex Nitinol Guidewire - Beudamed, MODIFICATION TO NITREX NITINOL GUIDEWIRE (K040345) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ev3, Inc
FDA Applicant
Ev3, Inc.

Sources (1)

  • FDA 510(k) K040345 24 fields · synced Sep 22, 2026