# K223419: Triever16 Curve

- Pathway: 510(k) (Special)
- Applicant: Inari Medical
- Decided: Mar 23, 2023 after 133 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 4.

## Indications for use
The Trieverl6 Curve 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 Trieverl6 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Trieverl6 Curve is not indicated for use with FlowTriever Catheters. The Trieverl6 Curve is also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

Source page: https://510kreport.com/device/K223419
Methodology: https://510kreport.com/methodology