# K250421: InThrill™ Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: May 12, 2025 after 88 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K901627 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223613: InThrill Thrombectomy System, Inari Medical, Inc. (2023) Summary page 5.

## Indications for use
The InThrill™ Thrombectomy System is indicated for: • The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. The InThrill™ Sheath is indicated for use as a conduit for the insertion of endovascular devices into the peripheral vasculature while minimizing blood loss associated with such insertions. The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature. The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.

Source page: https://510kreport.com/device/K250421
Methodology: https://510kreport.com/methodology