Peel-Away Introducer Sheath— 510(k) K254236

Name: FDA 510(k) clearance K254236
Creator: U.S. Food and Drug Administration
Published: 2026-02-09

Substantially Equivalent

VascuTech Medical, LLC

FDA 510(k) clearance K254236 for Peel-Away Introducer Sheath, Substantially Equivalent on 2026-02-09. Applicant: VascuTech Medical, LLC. Device class: 2.

Summary

VascuTech Medical's Peel-Away Introducer Sheath is filed under product code DYB, catheter introducer. The record doesn't describe the sheath beyond its name and that code name.

Class II, 21 CFR 870.1340. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

VascuTech Medical filed from Oaks, Pennsylvania. Review took 42 calendar days (December 29, 2025 to February 9, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: VascuTech Medical, LLC
Product code: Product code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2025-12-29
Decision date: 2026-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oaks, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

view all

K262674 — Giranel Guiding Sheath Set2026-10-15
K253526 — NAMIC Dilator and Sheath2026-07-29
K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
K261242 — SimplGuide2026-06-25
K261950 — Health Line Tearaway Introducer2026-06-22

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.