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Worker™ Guidewire 114035260

by Argon Medical Devices, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886333008056 UDI-DI Date16 Mar 2017ListedStatusListed GUDID: not in commercial distribution

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

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Worker™ Guidewire
Generic Name
Cardiac/peripheral vascular guidewire, single-use
Model / Ref / Catalog
114035260
Primary DI / UDI-DI
00886333008056
510(k) Number
FDA Product Code
DQX
GMDN Term
Cardiac/peripheral vascular guidewire, single-use
Device Class
Class II
Regulation Number
870.1330
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K160785)

Show all (10)

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No