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Hydrophilic Coating Guide Wire

by Suzhou Hengrui Disheng Medical Co., Ltd.

510(k) K193653

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 NumberK193653 Date26 Aug 2020ClearedStatusActive

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  • Withdrawn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, 22 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 coating guide wire, classified under product code DQX as a catheter guide wire. It is designed to facilitate the placement of catheters and other interventional devices within the vascular system by providing a smooth, low-friction surface when wetted.

The device is supplied by Suzhou Hengrui Disheng Medical Co., Ltd. and is intended for single use in clinical settings. It is regulated under Class II special controls and is subject to FDA 510(k) clearance procedures. Storage conditions and specific handling instructions are not detailed in the available data.

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