# K202345: FlowTriever Retrieval/Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical
- Decided: Dec 18, 2020 after 122 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: 3 generations back to K183198 (2018). 3 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191710: FlowTriever Retrieval/Aspiration System, Inari Medical (2019) Summary page 4.

## Most influential descendants
- 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
- 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

## Indications for use
Triever Catheters are 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. Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters 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/K202345
Methodology: https://510kreport.com/methodology