# K253419: Triever Duo Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Sep 18, 2026 after 352 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: 6 generations back to K183198 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213402: Triever24, Triever20, Inari Medical (2022) Summary page 5.

## Indications for use
The FlowTriever Retrieval/Aspiration System is indicated for: • The non-surgical removal of emboli and thrombi from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever Duo, a Triever Catheter within the FlowTriever Retrieval/Aspiration System, is indicated for: • Treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters. • Pressure Measurement

Source page: https://510kreport.com/device/K253419
Methodology: https://510kreport.com/methodology