# K180466: FlowTriever Retrieval/Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: May 17, 2018 after 85 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.
5 later devices descend from it; 3 cite it directly.
3 of 23 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
- K181325: FlowTriever Retrieval/Aspiration System (2018), 2 descendants of its own
- K181694: FlowTriever Retrieval/Aspiration System (2018), 1 descendant of its own
- K240397: AlphaVac MMA F1885 System (H787253020) (2024), 0 descendants of its own
- K202821: Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 (2020), 0 descendants of its own
- K182233: FlowTriever Retrieval/Aspiration System (2018), 0 descendants of its own

## Indications for use
The FlowTriever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. 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.

Source page: https://510kreport.com/device/K180466
Methodology: https://510kreport.com/methodology