EasyTrak 2 Stylet, Models 4826, 4829, 4832

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K052965 ↗

FDA Product Code

DRB

Models / Variants

4826

4829

4832.

Device Class

Class II

Regulation

21 CFR Part 870.1380

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 use of the EasyTrak 2 Stylet in a clinical setting?

  The EasyTrak 2 Stylet is designed to assist in the precise placement of implantable venous leads within the coronary venous vasculature during cardiovascular procedures. It acts as a guide to help navigate and position leads safely in electrophysiology laboratories or cardiac catheterization suites.

• Are the EasyTrak 2 Stylet models 4826, 4829, and 4832 reusable or intended for single-use?

  The EasyTrak 2 Stylet is explicitly supplied as a single-use device, meaning it is not intended for reuse after a single procedure. This ensures patient safety and sterility.

• How is the EasyTrak 2 Stylet packaged, and is it sterile?

  The EasyTrak 2 Stylet is supplied as a non-sterile item, meaning it requires sterilization by the facility before use. It is packaged for single-use procedures in electrophysiology or cardiac catheterization settings.

• What regulatory pathway was followed for FDA clearance of the EasyTrak 2 Stylet?

  The EasyTrak 2 Stylet underwent a Traditional 510(k) review process and was granted FDA clearance under the 510(k) number K052965. It is classified as a Class II device and falls under the Cardiovascular advisory committee category.