VascuTech Medical, LLC · Class II · Cleared Feb 9, 2026
| K-number | K254236 |
| Device name | Peel-Away Introducer Sheath |
| Applicant | VascuTech Medical, LLC |
| Product code | DYB |
| Device class | Class II |
| Decision date | Feb 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
The Peel-Away Introducer Sheath is a medical device designed for percutaneous (through-the-skin) introduction of catheters and other intravascular devices into blood vessels. It consists of an outer peelable sheath and a dilator, both with cylindrical cannulas, available in sizes ranging from 3.5 to 16 French and lengths of 5, 7, 10, and 13 centimeters. The device is single-use and limited-duration, sterilized with ethylene oxide.
The subject device uses HDPE with 20% BaSO4 for both sheath and dilator materials, compared to the predicate's unknown dilator material and PTFE/MDPE sheath. Both devices share identical design (winged hub on sheath, round hub on dilator), shape, sterilization method, and duration of use. The subject device offers a slightly narrower size range (3.5-16F versus 3-16F) and shorter maximum length (13 cm versus 30 cm).
ISO 10993-1:2025 for biocompatibility testing, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, hemolysis, and SC5B-9 complement activation. Nonclinical performance testing included compatibility, sheath leak, dimensional verification, rigidity, integrity, visual inspection, break force testing, and peel-away functionality.
View the full FDA submission: accessdata.fda.gov