K254236 is an FDA 510(k) clearance for the Peel-Away Introducer Sheath. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by VascuTech Medical, LLC (Oaks, US). The FDA issued a Cleared decision on February 9, 2026, 42 days after receiving the submission on December 29, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K254236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2025 |
| Decision Date | February 09, 2026 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |