Cardiocycle Medical(Suzhou) Co., Ltd. · Class II · Cleared Apr 23, 2026
| K-number | K254248 |
| Device name | Introducer Sheath Set |
| Applicant | Cardiocycle Medical(Suzhou) Co., Ltd. |
| Product code | DYB |
| Device class | Class II |
| Decision date | Apr 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
The Introducer Sheath Set is a vascular access device consisting of a sheath and dilator used to provide a conduit for insertion of endovascular devices while minimizing blood loss. It features a hydrophilic coating on the sheath, is sterilized with ethylene oxide, and is disposable. The sheath and dilator are offered in various sizes with internal diameters ranging from 3.9–8.6 mm and effective lengths from 150–795 mm.
The subject device is identical in principles of operation, components, design, materials, structural composition, sterilization, and manufacturing process to the predicate device (K251838). The only difference is the addition of models with new shorter effective lengths of the sheath and dilator compared to the predicate device.
Not stated in this summary.
The Introducer Sheath Set is substantially equivalent to predicate device K251838 because it is identical in intended use, indications for use, principles of operation, components, design, materials, and manufacturing. The only modification is the addition of shorter length models, which was supported by a reference device (Tearaway Introducer Sheath K153533) demonstrating the safety and effectiveness of shorter lengths in the intended vasculature.
View the full FDA submission: accessdata.fda.gov