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Worker Guidewire

by Argon Medical Devices, Inc.

510(k) K160785

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160785↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK160785 Date8 Dec 2016ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1792-2020 FDA Class I initiated 4 Dec 2019
    • Terminated Z-1791-2020 FDA Class I initiated 4 Dec 2019

    The stiffness of the soft end of the guidewire caused tissue perforation.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 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 Worker Guidewire is a guidewire (DQX product code) designed to assist in the placement of catheters within the coronary and peripheral vasculature. Its construction includes a large stainless steel core with stainless steel flat-wire coils, providing enhanced rigidity, tactile feedback, and support during vascular procedures. The device is engineered for compatibility with medical devices featuring a lumen larger than its specified diameter and shorter than its labeled length, though physician judgment is required for optimal selection.

The Worker Guidewire is supplied as a reusable device, featuring a pre-coated PTFE surface to reduce friction during use. It is intended for interventional settings and adheres to FDA 510(k) clearance (K160785) and MDR regulatory standards. Compatibility and procedural use depend on the labeled dimensions, with no explicit MRI safety classification or single-use designation stated. Storage and handling follow standard interventional medical device protocols.

From the manufacturer

The guidewires are compatible with medical devices with a lumen larger than the diameter size listed on the label and shorter than the labelled length. Physician judgement required to select the appropriate guidewire compatible with other medical devices to be used.

Source: argonmedical.com

WORKER™ Amplatz guidewires are manufactured with a pre-coating technique offering a safe and flexible guidewire. The PTFE coating used reduces friction. The Large Stainless Steel (SS) Core with SS Flat-Wire Coils increases rigidity, tactile feedback, and support while advancing catheters through the vasculature.

Source: argonmedical.com

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Questions

AI-generated answers, 18 Sep 2026

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

  • Is the Worker Guidewire designed for single-use or can it be reused in multiple procedures?

    The Worker Guidewire is explicitly labeled as a reusable device. Its design includes a pre-coated PTFE surface to minimize friction during use, which supports repeated applications. However, proper cleaning, sterilization, and maintenance per manufacturer guidelines are required to ensure safety and performance across procedures.

  • What types of vasculature is the Worker Guidewire intended to assist with during catheter placement?

    The Worker Guidewire is engineered to assist in coronary and peripheral vasculature procedures. Its enhanced rigidity and tactile feedback are particularly useful for navigating challenging anatomical paths, though physician judgment is advised when selecting the appropriate size and model for specific cases.

  • How does the Worker Guidewire’s construction contribute to its functionality during vascular procedures?

    The Worker Guidewire features a large stainless steel core with stainless steel flat-wire coils, which provides rigidity, tactile feedback, and support—key attributes for precise catheter placement. The design ensures stability while navigating tortuous vessels, reducing the risk of misalignment or procedural complications.

  • What compatibility considerations should clinicians keep in mind when pairing the Worker Guidewire with other devices?

    The Worker Guidewire is compatible with catheters that have a lumen larger than its specified diameter and shorter than its labeled length. However, the manufacturer emphasizes that physician judgment is required to ensure optimal selection for each procedure, as compatibility depends on procedural context and specific device dimensions.

  • Are there any special storage or handling requirements for the Worker Guidewire beyond standard interventional device protocols?

    While the Worker Guidewire follows standard interventional medical device storage and handling protocols, its reusable nature means additional care is needed—such as cleaning, sterilization, and maintenance—to preserve its performance. The manufacturer’s instructions should be consulted to ensure proper upkeep between uses.