# K191368: FlowTriever Retrieval/Aspiration System

- Pathway: 510(k) (Special)
- Applicant: Inari Medical
- Decided: Jun 17, 2019 after 26 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: 1 generation back to K183198 (2018). 1 ancestor in all.
21 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183198: FlowTriever Retrieval/Aspiration System, Inari Medical (2018) Summary page 4.

## Most influential descendants
- K191710: FlowTriever Retrieval/Aspiration System (2019), 20 descendants of its own
- K202345: FlowTriever Retrieval/Aspiration System (2020), 14 descendants of its own
- K211013: FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 (2021), 12 descendants of its own
- K213402: Triever24, Triever20 (2022), 9 descendants of its own
- K251189: Aventus Thrombectomy System (2025), 3 descendants of its own

## 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/K191368
Methodology: https://510kreport.com/methodology