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Easy Pass Hydrophilic Coated Vascular Guidewire

by Galt Medical Corp.

510(k) K033542

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 found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K033542↗

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 · Special NumberK033542 Date5 Dec 2003ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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.

This device is a hydrophilic coated vascular guidewire (Device Type: DQX – Guidewire, Hydrophilic Coated), designed to facilitate the navigation of catheters and other instruments through blood vessels. Its hydrophilic coating reduces friction, improving ease of passage and reducing trauma to vascular walls during interventional procedures such as angioplasty or stent placement.

The Easy Pass Hydrophilic Coated Vascular Guidewire is supplied sterile and intended for single-use. It is classified under the FDA’s 510(k) clearance and MDR requirements, with a Special 510(k) clearance via the Cardiovascular (CV) Advisory Committee. Available in specified lengths and diameters as per manufacturer specifications, it must be stored in a clean, dry environment to maintain sterility and performance.

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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.

  • What types of medical procedures is the Easy Pass Hydrophilic Coated Vascular Guidewire commonly used for?

    The Easy Pass Hydrophilic Coated Vascular Guidewire is primarily designed to assist in navigating catheters and other instruments through blood vessels during procedures like angioplasty or stent placement. Its hydrophilic coating reduces friction, which helps minimize trauma to the vessel walls and improves the smooth passage of the guidewire, making it particularly useful in complex or tortuous vascular pathways.

  • Is the Easy Pass Hydrophilic Coated Vascular Guidewire intended for reuse, or is it meant to be used only once?

    The device is explicitly labeled as intended for single-use only. This is standard for hydrophilic-coated guidewires to ensure sterility and performance consistency, as reuse could compromise the coating’s integrity and introduce infection risks.

  • How should I store the Easy Pass Hydrophilic Coated Vascular Guidewire to keep it in good condition?

    The manufacturer recommends storing the guidewire in a clean, dry environment to preserve its sterility and performance. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions could degrade the hydrophilic coating or compromise the packaging.

  • What regulatory pathways does the Easy Pass Hydrophilic Coated Vascular Guidewire follow, and how was its approval determined?

    The device received a Special 510(k) clearance through the FDA’s Cardiovascular (CV) Advisory Committee, with a decision code of SESE (Substantially Equivalent). It also complies with the EU’s Medical Device Regulation (MDR). The clearance process involved demonstrating equivalence to a predicate device while addressing specific safety and performance criteria for hydrophilic-coated guidewires.