# K182233: FlowTriever Retrieval/Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical
- Decided: Oct 15, 2018 after 59 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K832023 (1983). 22 ancestors in all.
No later device cites it as a predicate yet.
3 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181694: FlowTriever Retrieval/Aspiration System, Inari Medical (2018) Summary page 4.

## Recalls of this device
- Mar 23, 2020 · Class II · Z-2299-2020: The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device mu

## Indications for use
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/K182233
Methodology: https://510kreport.com/methodology