# K201541: FlowTriever Retrieval/Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical
- Decided: Dec 4, 2020 after 178 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: 4 generations back to K832023 (1983). 17 ancestors in all.
4 later devices descend from it; 2 cite it directly.
3 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143563: Infusion Aspiration Catheter System, Inari Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K220600: Artix Thrombectomy Device (2022), 2 descendants of its own
- K241894: Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (2024), 1 descendant of its own
- K262538: Artix™ MT;Artix™ Thin-Walled Sheath (2026), 0 descendants of its own
- K250088: FlowTriever2 Catheter (2025), 0 descendants of its own

## Indications for use
The FlowTriever2 Catheter is indicated for: • The non-surgical removal of emboli and thrombi from peripheral blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K201541
Methodology: https://510kreport.com/methodology