Cleared Traditional

Peel-Away Introducer Sheath

K254236 · VascuTech Medical, LLC · Cardiovascular
Feb 2026
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K254236 is an FDA 510(k) clearance for the Peel-Away Introducer Sheath, 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 review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K254236 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340