EASYTRAK 2 STYLET - 4829

No FDA recalls found in the data synced 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

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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.