# K181694: FlowTriever Retrieval/Aspiration System

- Pathway: 510(k) (Special)
- Applicant: Inari Medical
- Decided: Jul 27, 2018 after 30 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: 7 generations back to K832023 (1983). 21 ancestors in all.
1 later device descends from it; 1 cites 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)
- K181325: FlowTriever Retrieval/Aspiration System, Inari Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- 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/K181694
Methodology: https://510kreport.com/methodology