Hi-Torque Command Guide Wire Family
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122573 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 Guide Wire Family is a series of guide wires designed for use in peripheral vascular procedures. These devices are classified as Guidewires and are intended for facilitating the placement of catheters and stents in arteries such as the femoral, popliteal, and infra-popliteal regions. Their design emphasizes torque transmission and flexibility to navigate complex vascular anatomies during interventions like percutaneous transluminal angioplasty (PTA).
The guide wires are supplied as single-use, sterile devices and are regulated under the FDA 510K clearance (K122573) as substantially equivalent to predicate devices. They are intended for use in fluoroscopy-guided procedures and come in varying distal stiffness profiles to accommodate different clinical needs. Storage and handling must comply with sterile medical device protocols, and compatibility with compatible stent devices is noted in the specifications.
Frequently asked questions
What is the Hi-Torque Command Guide Wire Family used for?
This guide wire family is designed specifically for peripheral vascular procedures, helping clinicians place catheters and stents in arteries such as the femoral, popliteal, and infra-popliteal regions. Its torque-transmitting design and flexibility make it ideal for navigating complex vascular anatomies during interventions like percutaneous transluminal angioplasty (PTA). The varying distal stiffness profiles ensure adaptability to different clinical scenarios.
Are the Hi-Torque Command Guide Wires single-use or reusable?
These guide wires are supplied as single-use devices. This design choice ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for sterile medical devices in vascular procedures. Single-use also eliminates the need for reprocessing, streamlining workflow in clinical settings.
How should the Hi-Torque Command Guide Wire Family be stored?
The guide wires must be stored according to sterile medical device protocols to maintain their integrity and sterility. This includes keeping them in their original packaging, away from direct sunlight or extreme temperatures, and ensuring the packaging remains uncompromised. Proper storage prevents contamination and preserves the device’s performance for its intended use in fluoroscopy-guided procedures.
What regulatory clearance does the Hi-Torque Command Guide Wire Family hold?
The Hi-Torque Command Guide Wire Family holds FDA 510K clearance under the reference number K122573. This clearance indicates that the device is deemed substantially equivalent to a predicate device, meaning it meets the regulatory standards for safety and effectiveness as determined by the FDA. The clearance is specific to its intended use in peripheral vascular procedures.
What types of distal stiffness profiles are available in the Hi-Torque Command Guide Wire Family?
The family includes guide wires with varying distal stiffness profiles, tailored to accommodate different clinical needs during peripheral vascular interventions. These profiles allow clinicians to select the appropriate wire for specific anatomical challenges, ensuring optimal navigation and support during catheter or stent placement. The exact profiles are detailed in the product specifications.
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™ 18 Workhorse Guidewires | Abbott, PDF Abbott Vascular Peripheral Guide Wires, Hi-Torque Command by Abbott Vascular Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122573 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular Inc.
- FDA Applicant
- Abbott Vascular, Inc.
Sources (1)
- FDA 510(k) K122573 24 fields · synced Oct 1, 2026