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Naviguide Hydrophilic Coated Guidewire

by Meadox Medicals, Div. Boston Scientific Corp.

510(k) K922674

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 NumberK922674 Date21 Dec 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  • Withdrawn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, 20 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 Naviguide Hydrophilic Coated Guidewire is a guidewire designed for vascular procedures. It features a hydrophilic coating to enhance lubricity and ease of navigation through blood vessels, reducing friction and improving maneuverability during catheterization or angioplasty. This device is intended for use in coronary and peripheral vascular interventions, where precise placement and minimal trauma to vessel walls are critical.

This guidewire is supplied as a single-use, non-sterile device and requires sterilization prior to use. It is classified under product code DQX and has received FDA 510(k) clearance (K922674) as substantially equivalent to a predicate device. The device is intended for use in controlled clinical settings, such as cardiac catheterization labs, and must be stored according to manufacturer guidelines to maintain integrity. No MRI safety information is specified in the available data.

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