# K231848: Triever20 Curve (21-201)

- Pathway: 510(k) (Special)
- Applicant: Inari Medical, Inc.
- Decided: Jul 21, 2023 after 28 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 Triever20 Curve (21-201) is used coaxially within the Triever24 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 Triever20 Curve (21-201) is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever20 Curve (21-201) Catheter is not indicated for use with FlowTriever Catheters. Triever20 Curve (21-201) is also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters. The Triever20 Curve (21-201) must be used within the Triever24.

Source page: https://510kreport.com/device/K231848
Methodology: https://510kreport.com/methodology