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ACS Hi-Torque Cross IT 100XT, 200XT, and 300XT Guide Wires with Hydrocoat Hydrophilic Coating

by Guidant Corp.

510(k) K990639

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 · Special NumberK990639 Date25 Mar 1999ClearedStatusActive

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  • Withdrawn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 ACS Hi-Torque Cross IT 100XT, 200XT, and 300XT Guide Wires with Hydrocoat Hydrophilic Coating are coronary guide wires designed for use in percutaneous coronary interventions. These devices feature a hydrophilic coating to improve navigability through complex and tortuous coronary vessels, facilitating precise catheter placement during procedures such as angioplasty and stenting. The cross-shaped tip enhances stability and control within the coronary anatomy, while the hi-torque design ensures reliable torque transmission for effective vessel manipulation. The varying lengths (100XT, 200XT, 300XT) accommodate different patient anatomies and procedural requirements.

These guide wires are supplied as single-use, sterile devices intended for use in interventional cardiology laboratories. They are classified under FDA product code DQX and were granted Special 510(k) clearance through the Cardiovascular (CV) Advisory Committee. The hydrophilic coating reduces friction, aiding in smoother advancement through vascular pathways. Storage instructions and MRI safety data are not specified in the regulatory submission, but compliance with standard sterile barrier packaging and handling protocols is implied. The devices are manufactured by Guidant Corp., with regulatory filing conducted in 1999 under 510(k) number K990639.

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