# K212392: Intri24 Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Apr 1, 2022 after 242 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: 4 generations back to K032073 (2003). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121234: Gore (R) Dryseal Sheath with Hydrophilic Coating, W. L. Gore & Associates, Inc. (2012) Summary page 4.

## Most influential descendants
- K230331: Protrieve Sheath (2023), 2 descendants of its own
- K233646: Intri24 Introducer Sheath (52-101) (2023), 1 descendant of its own
- K252508: Intri26 Introducer Sheath (2025), 0 descendants of its own
- K253323: Protrieve Sheath (2025), 0 descendants of its own
- K233815: ClotTriever Sheath (2023), 0 descendants of its own

## Indications for use
The Intri24 Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

Source page: https://510kreport.com/device/K212392
Methodology: https://510kreport.com/methodology