ABBOTT MEDICAL · Class II · Cleared Jul 25, 2025
| K-number | K250552 |
| Device name | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire |
| Applicant | ABBOTT MEDICAL |
| Product code | DQX |
| Device class | Class II |
| Decision date | Jul 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1330 |
The Hi-Torque Command 14 ST and MT Guide Wires are catheter guide wires with a maximum diameter of 0.0144 inches, available in 210 cm and 300 cm lengths. They are indicated to facilitate placement of balloon dilatation catheters during percutaneous transluminal angioplasty in femoral, popliteal, and infra-popliteal arteries, and may be used with stent devices and to reach target lesions.
The subject device has identical design, materials composition, and technological characteristics to the predicate device K240997. Both are available with short taper (ST) or medium taper (MT) configurations and offer straight or angled, shapeable distal tips.
Not stated in this summary.
The subject and predicate devices share identical intended use, indications for use, device design, material composition, and technological characteristics. Non-clinical testing including friction, kink resistance, bending durability, fracture, torsional strength, tip tensile strength, particulates, rotational accuracy, coating integrity, and simulated use confirmed that labeling changes do not negatively impact safety and effectiveness, establishing substantial equivalence.
View the full FDA submission: accessdata.fda.gov