# K252508: Intri26 Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Dec 17, 2025 after 131 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: 6 generations back to K183198 (2018). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233646: Intri24 Introducer Sheath (52-101), Inari Medical, Inc. (2023) Summary page 5.
- K213402: Triever24, Triever20, Inari Medical (2022) Summary page 5.

## Indications for use
The Intri26 Introducer Sheath is indicated: • To provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions. • For the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

Source page: https://510kreport.com/device/K252508
Methodology: https://510kreport.com/methodology