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FDA 510(k)

Peel-Away Introducer Sheath

K-Number: K254236 · 2026-02-09

ApplicantVascuTech Medical, LLC
Decision Date2026-02-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Peel-Away Introducer Sheath is a medical device manufactured by VascuTech Medical, LLC. It received FDA 510(k) clearance on 2026-02-09 under approval number K254236. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peel-Away Introducer Sheath?

Peel-Away Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-02-09. It is manufactured by VascuTech Medical, LLC. The 510(k) number is K254236.

When was Peel-Away Introducer Sheath approved by the FDA?

Peel-Away Introducer Sheath received FDA 510(k) clearance on 2026-02-09, under approval number K254236.

What company makes Peel-Away Introducer Sheath?

Peel-Away Introducer Sheath is manufactured by VascuTech Medical, LLC.

What is the FDA product code for Peel-Away Introducer Sheath?

The FDA product code for Peel-Away Introducer Sheath is DYB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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