# K192332: ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath

- Pathway: 510(k) (Special)
- Applicant: Inari Medical
- Decided: Sep 20, 2019 after 24 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: 8 generations back to K832023 (1983). 21 ancestors in all.
No later device cites it as a predicate yet.
3 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182531: ClotTriever Thrombectomy System, Inari Medical (2018) Summary page 4.

## Indications for use
The ClotTriever Thrombectomy System is indicated for: The non-surgical removal of soft thrombi and emboli from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K192332
Methodology: https://510kreport.com/methodology