Argon Medical Devices, Inc. · Class II · Cleared Dec 15, 2025
| K-number | K253741 |
| Device name | VStick Vascular Access Set |
| Applicant | Argon Medical Devices, Inc. |
| Product code | DYB |
| Device class | Class II |
| Decision date | Dec 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
The V•Stick™ Vascular Access Set is a vascular access device consisting of a 4F or 5F coaxial introducer set with dilators, a 21-gauge entry needle, and a 0.018" x 40cm guidewire with an articulatable tip. It is intended for use in the introduction and placement of guidewires and/or catheters.
The device modification involved replacing the Nitinol with Palladium/Rhenium guidewire with a 0.018" x 40cm Nitinol core and Stainless Steel coil tip guidewire. All other components—the introducer set, dilators, and needle—remain unchanged from the predicate device.
ISO 14971:2019 (risk management), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (acute systemic toxicity and pyrogenicity), and ISO 10993-4 (hemocompatibility, complement activation, thrombogenicity).
There is no change in intended use or fundamental scientific technology between the proposed modified device and the predicate K130730. The guidewire material change was evaluated through design failure modes analysis and risk management, with all acceptance criteria met in verification testing. Biocompatibility and performance testing were leveraged from predicates K223791 and K130730, demonstrating that the modified device meets product specifications and is substantially equivalent.
View the full FDA submission: accessdata.fda.gov