# K211013: FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24

- Pathway: 510(k) (Special)
- Applicant: Inari Medical, Inc.
- Decided: Apr 30, 2021 after 25 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 K183198 (2018). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202345: FlowTriever Retrieval/Aspiration System, Inari Medical (2020) Summary page 4.

## Most influential descendants
- K213402: Triever24, Triever20 (2022), 9 descendants of its own
- K223929: Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) (2023), 1 descendant of its own
- K223897: Excipio LV Thrombectomy Device (2023), 1 descendant of its own
- K253419: Triever Duo Catheter (2026), 0 descendants of its own
- K254035: Mayumi™ Thrombectomy System (2026), 0 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. Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

Source page: https://510kreport.com/device/K211013
Methodology: https://510kreport.com/methodology