Vp Wire GW140ST (.014 165cm, Standar), Model GW140ST; Vp Wire GW140SO (.014 165cm, Soft) Model GW140SO

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

510(k) Number

K051062 ↗

FDA Product Code

DQX

Models / Variants

Vp Wire GW140ST (.014 165cm, Standar), Model GW140ST

Vp Wire GW140SO (.014 165cm, Soft) Model GW140SO

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What are the VP Wire GW140ST and GW140SO designed for?

  The VP Wire GW140ST and GW140SO are specifically engineered for percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) procedures. They assist in guiding balloon dilatation catheters through coronary and peripheral blood vessels, providing support and flexibility to navigate complex vascular anatomy. The design ensures precise catheter placement while minimizing trauma to the vessel walls.

• How are the VP Wire GW140ST and GW140SO supplied, and what is their sterility status?

  Both the VP Wire GW140ST and GW140SO are supplied as reusable devices, but they are intended for single-use per procedure to maintain sterility. This ensures each procedure begins with a sterile instrument, reducing the risk of contamination. After use, they should be disposed of or reprocessed according to manufacturer guidelines if reused in a controlled clinical setting.

• What distinguishes the GW140ST from the GW140SO in terms of flexibility?

  The GW140ST is labeled as a standard guidewire, offering a balanced stiffness for navigation, while the GW140SO is designed as a soft guidewire, providing enhanced flexibility for delicate or tortuous vessels. Both share the same .014-inch diameter and 165cm length but differ in their mechanical properties to suit varying clinical needs.

• Are these guidewires compatible with MRI equipment?

  There are no known MRI safety restrictions for the VP Wire GW140ST or GW140SO. However, as with all metallic medical devices, their use in MRI environments should follow standard safety protocols to avoid potential risks such as heating or displacement. Always verify compatibility with your facility’s MRI guidelines before use.

• How should the VP Wire GW140ST/165CM be stored to preserve functionality?

  Storage must adhere to manufacturer guidelines to preserve sterility and functionality. This typically includes keeping the guidewires in a clean, dry environment away from direct sunlight or extreme temperatures. If stored for reuse, follow established reprocessing protocols (e.g., cleaning, sterilization) to ensure they remain safe and effective for subsequent procedures. Always check the packaging for specific storage instructions.