Standard 0.025 Straight, Standard 0.025 Angled, Standard 0.032 Straight, Standard 0.032 Angled, Soft 0.035 Straight, Sof

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

510(k) Number

K983346 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Steerable Stylet Accessory

  Class II

  FDA 510(k) K053019 Active Cleared 3 Mar 2006

• Rapido Cut-Away Bleedback Control Valve (Bbcv), Model 7568

  Class II

  FDA 510(k) K031903 Active Cleared 3 Mar 2004

• Modification to Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,

  Class II

  FDA 510(k) K993588 Active Cleared 17 Nov 1999

• Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K031678 Active Cleared 26 Aug 2003

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

  Class II

  FDA 510(k) K990639 Active Cleared 25 Mar 1999

• Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model Vh-3000 Open recall

  Class II

  FDA 510(k) K052274 Active Cleared 21 Sep 2005

See all devices from Guidant Corp. →

• What is the primary clinical purpose of the Standard and Soft Guide Wire?

  This device is designed for cardiovascular use to assist clinicians in the navigation and precise placement of various medical instruments within the vascular system.

• What size and tip configurations are available for this guide wire?

  The device is available in three diameter sizes, including 0.025, 0.032, and 0.035. Each size option is offered with either a straight or an angled tip configuration to suit specific procedural requirements.

• What is the regulatory status of the Guidant Corp. guide wire?

  The Standard and Soft Guide Wire has received FDA 510k clearance, which indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.