Liquet Medical, Inc. · Class II · Cleared Feb 17, 2026
| K-number | K260149 |
| Device name | Versus Catheter (VS110-9NB) |
| Applicant | Liquet Medical, Inc. |
| Product code | QEY |
| Device class | Class II |
| Decision date | Feb 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.5150 |
The Versus™ Catheter (VS110-9NB) is a dual-tip, infusion catheter designed to deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of both lungs via a single venous access site. It also enables hemodynamic monitoring through direct intracardiac and pulmonary artery pressure measurement via an external pressure transducer.
The subject device is a 9 French catheter with a 0.035" guidewire for the primary tip and 0.035" guidewire for the secondary tip (compared to the predicate's 0.014" secondary guidewire). The key difference is the removal of the flow-directed balloon lumen present in the predicate device, eliminating the need for an associated inflatable balloon, syringe, and stopcock. All other characteristics—working length (100–107 cm), infusion segment length (12 cm), radiopaque markers, pressure measurement capability, materials, sterilization, and biocompatibility—remain substantially the same.
ISO 10993 (biocompatibility evaluation), ISO 11135:2014 (sterilization validation), IEC 62366-1:2015 (human factors/usability testing), ASTM D4332-22 (packaging conditioning), ASTM D4169 (simulated distribution testing), and FDA Draft Guidance on biocompatibility risk management processes.
View the full FDA submission: accessdata.fda.gov