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GUIDER-22

by Target Therapeutics

510(k) K914031

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914031 Date11 Feb 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 19 Sep 2026

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

The Guider-22 is a wire, guide, catheter (product code DQX) designed for use in cardiovascular procedures. It is intended as a steerable guidewire to facilitate the placement of catheters or other interventional devices within blood vessels, providing support and navigation during procedures such as angioplasty or stent placement.

This device is supplied as a single-use, non-sterile product and is regulated under FDA 510(k) clearance (K914031) with a classification of Class II under regulation 870.1330. It was reviewed by the Cardiovascular (CV) advisory committee and granted a Substantially Equivalent (SESE) decision in February 1992. No additional sterility or MRI safety information is provided in the specifications.

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Questions

AI-generated answers, 19 Sep 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 Guider-22 primarily used for in medical procedures?

    The Guider-22 is a steerable guidewire designed to assist in cardiovascular procedures. It helps navigate and position catheters or other interventional tools within blood vessels, providing stability during tasks like angioplasty or stent placement. Its role is to act as a supportive framework for precise device placement.

  • Is the Guider-22 intended for single-use or reusable applications?

    The Guider-22 is explicitly supplied as a single-use device. This means it is meant to be used once per patient and then discarded, ensuring patient safety and reducing the risk of contamination or cross-infection.

  • How is the Guider-22 packaged and stored before use?

    The Guider-22 is provided in a non-sterile state, meaning it requires terminal sterilization (e.g., ethylene oxide or gamma irradiation) by the healthcare facility before use. Since it is single-use, storage should follow standard protocols for non-sterile medical devices until sterilized, then handled under aseptic conditions.

  • What regulatory pathway was followed for FDA clearance of the Guider-22?

    The Guider-22 received FDA 510(k) clearance under the traditional review process, classified as Class II (regulation 870.1330). It was deemed Substantially Equivalent (SESE) to a predicate device by the Cardiovascular (CV) Advisory Committee in February 1992, confirming its safety and effectiveness for its intended use.