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Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240997

by Abbott Medical

Identifiers

510(k) Number
K240997 FDA 510(k)
FDA Product Code
DQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire are guidewires designed for use in percutaneous transluminal angioplasty (PTA) and related interventions. These devices are engineered to assist in the placement of balloon dilatation catheters and compatible stent devices within peripheral arteries, including the femoral, popliteal, and infra-popliteal regions. Their high-torque characteristics enhance navigability through complex vascular anatomy, improving procedural control and success.

These guidewires are supplied as single-use, sterile devices and are intended for use in elective and emergency vascular interventions. They are classified under product code DQX and were granted FDA 510(k) clearance via a traditional review pathway by the Cardiovascular (CV) Advisory Committee. Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to use.

Frequently asked questions

What types of vascular procedures are these guidewires specifically designed for, and why are they considered advantageous in those settings?

The Hi-Torque Command 14 ST and MT Guide Wires are designed for percutaneous transluminal angioplasty (PTA) and related interventions, including the placement of balloon catheters and compatible stents in peripheral arteries such as the femoral, popliteal, and infra-popliteal regions. Their high-torque characteristics make them particularly advantageous in complex vascular anatomies, as they enhance navigability and procedural control, which can improve success rates in challenging cases.

Are these guidewires intended for reuse, or are they meant to be used only once? How should they be stored to maintain sterility?

These guidewires are single-use devices, meaning they are not designed for reuse. To ensure sterility before use, they must be stored and handled according to standard sterile medical device protocols, as outlined in the manufacturer’s instructions. Improper storage could compromise their integrity and safety.

How do I know which model (ST or MT) is best suited for my procedure, and are there any differences between them?

The Hi-Torque Command 14 ST and MT guide wires are both designed for peripheral vascular interventions, but their specific differences (such as torque response, tip flexibility, or core wire composition) are not detailed in the provided data. The choice between them should be based on clinical judgment, procedural requirements, and compatibility with the intended catheter or stent system. Consulting the manufacturer’s technical documentation or a vascular specialist is recommended for optimal selection.

What regulatory pathway was followed for FDA clearance of these guidewires, and what does that mean for their safety and effectiveness?

These guidewires received FDA 510(k) clearance through a traditional review pathway, with a decision from the Cardiovascular (CV) Advisory Committee. This means the manufacturer demonstrated that their device is substantially equivalent (SESE) to a legally marketed predicate device in terms of technology and safety. While this does not imply direct approval for specific clinical uses, it indicates that the FDA reviewed and found the device to meet applicable regulatory standards for safety and performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hi-Torque Command™ Workhorse Guidewires | Abbott, Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide ..., Peripheral Intervention Guidewires Full Portfolio | Abbott

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA 510(k) K240997 24 fields · synced Sep 19, 2026