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Accutrac Xt Intravascular Guide Wire (Floppy) Model 2403/(Flex) Model 2404

by Cardio Metrics, Inc. 510(k)

Active United States

510(k) K961777

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961777 Date31 Jul 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQX
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An intravascular guide wire is a device used to facilitate the placement of catheters within blood vessels. The Accutrac Xt Intravascular Guide Wire is available in floppy (Model 2403) and flex (Model 2404) configurations.

This device received FDA 510(k) clearance under K961777 on July 31, 1996, and is classified under product code DQX for cardiovascular applications. It is manufactured by Cardio Metrics, Inc. and supplied as a single-use, sterile device for intravascular use.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Accutrac Xt Intravascular Guide Wire used for?

    The Accutrac Xt Intravascular Guide Wire is used to facilitate the placement of catheters within blood vessels, providing support and navigation during intravascular procedures.

  • How is the Accutrac Xt Intravascular Guide Wire supplied and is it reusable?

    The device is supplied as a single-use, sterile product, meaning it is intended for one procedure only and must be discarded after use to prevent infection and ensure performance integrity.

  • What models are available for the Accutrac Xt Intravascular Guide Wire and how do they differ?

    The Accutrac Xt Intravascular Guide Wire is available in two configurations: Model 2403 (floppy) and Model 2404 (flex), differing in tip flexibility to suit varying procedural needs and vessel characteristics.