Hi-Torque Command 18 Guide Wire
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152404 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 18 Guide Wire is a peripheral guidewire designed for endovascular procedures. It features high torque transmission and a reinforced structure to facilitate navigation through complex vascular anatomy, including occlusions and tortuous pathways. The device is categorized as a guidewire, optimized for support and flexibility in critical interventions such as chronic limb-threatening ischemia (CLTI).
This guidewire is supplied in two variants: the HT Command 18 ST, with a 10 cm nitinol distal tip offering high support and a 4 g tip load for crossing occlusions, and the HT Command 18 LT, with a 25 cm nitinol distal tip providing flexible support and a softer 4 g tip load for navigating tortuous vessels. It is intended for single-use and is not MRI-safe. The device holds an FDA 510(k) clearance under the Special 510(k) program, classified under product code DQX. Storage and handling must adhere to sterile packaging guidelines as specified by the manufacturer.
Frequently asked questions
What are the key differences between the HT Command 18 ST and HT Command 18 LT guide wires, and which one should I choose for my procedure?
The HT Command 18 ST features a 10 cm nitinol distal tip with high support, ideal for crossing occlusions due to its stiffer design and 4 g tip load. In contrast, the HT Command 18 LT has a 25 cm nitinol distal tip for navigating tortuous vessels, offering more flexibility while maintaining the same 4 g tip load. Choose the ST for challenging blockages or the LT for winding, narrow pathways—both are optimized for single-use in endovascular procedures like CLTI interventions.
Is the Hi-Torque Command 18 Guide Wire reusable, or is it designed for one-time use only?
The device is explicitly intended for single-use only. It comes in sterile packaging, and reuse is not supported by the manufacturer’s design or guidelines. Discarding it after one procedure ensures compliance with sterility and safety protocols.
Can this guide wire be used in patients who require MRI scans, or does it have MRI-related restrictions?
The Hi-Torque Command 18 Guide Wire is not MRI-safe. If a patient requires MRI imaging post-procedure, the wire must be fully removed before the scan. Always confirm removal and consult MRI safety guidelines to avoid complications.
How should I store the Hi-Torque Command 18 Guide Wire to maintain its sterility and functionality?
Storage must follow the manufacturer’s sterile packaging guidelines. Keep the device in its original, unopened packaging until ready for use, and avoid exposure to moisture, extreme temperatures, or physical damage. Once opened, use immediately to preserve sterility and performance.
What regulatory pathway was followed for FDA clearance of this guide wire, and what does that mean for its use?
The Hi-Torque Command 18 Guide Wire received FDA 510(k) clearance under the Special 510(k) program, classified under product code DQX. This means it was deemed substantially equivalent to a legally marketed predicate device after review by the Cardiovascular (CV) Advisory Committee. Clinically, this clearance confirms its safety and effectiveness for the intended use in endovascular procedures, but always verify compliance with current FDA and institutional protocols.
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™ 18 Workhorse Guidewires | Abbott, Hi-Torque Command™ Workhorse Guidewires | Abbott, Hi-Torque Command™ 18 Guide Wire - Endovascular | Medproduct, DeviceMD - Hi-Torque Command™ 18
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152404 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA 510(k) K152404 24 fields · synced Sep 19, 2026