# K254236: Peel-Away Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: VascuTech Medical, LLC
- Decided: Feb 9, 2026 after 42 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000313 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer, Galt Medical Corp. (2016) Summary page 5.

## Indications for use
The Peel-Away Introducer Sheath is intended for the percutaneous introduction of catheters and other intravascular devices into the vasculature.

Source page: https://510kreport.com/device/K254236
Methodology: https://510kreport.com/methodology