Sorin Group Italia S.R.L. · Class II · Cleared Dec 19, 2025
| K-number | K253616 |
| Device name | ProtekDilate Vascular Access Kit |
| Applicant | Sorin Group Italia S.R.L. |
| Product code | DRE |
| Device class | Class II |
| Decision date | Dec 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1310 |
The ProtekDilate Vascular Access Kit is a single-use sterile device comprising eight vascular dilators in sizes 8/10 to 30 French, along with an introducer needle, guidewires, scalpel, and syringe. It is intended for use by trained physicians to assist in vessel cannulation during percutaneous catheterization procedures.
The device uses dilators with ABS hubs accepting 0.035" and 0.038" guidewires. Key modifications from the predicate include addition of dilator sizes 8/10, 16, 28, and 30 Fr; increased durometer from 90A to 95A; hub material change from PVC to ABS; and packaging change from pouch to tray configuration.
Not stated in this summary.
The ProtekDilate is substantially equivalent to the predicate ProtekDuo Venous Dilator Set (K162181) because it maintains identical device technology, principle of operation, sterilization method, and shelf-life. Modifications are minor and supported by verification and validation testing including deflection, tensile, sterilization, shelf-life, biocompatibility, and package integrity studies, all of which met acceptance criteria.
View the full FDA submission: accessdata.fda.gov