# K163549: ClotTriever Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Feb 16, 2017 after 62 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 K832023 (1983). 17 ancestors in all.
6 later devices descend from it; 1 cites it directly.
3 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143563: Infusion Aspiration Catheter System, Inari Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K173470: ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath (2017), 5 descendants of its own
- K180329: ClotTriever Thrombectomy System (2018), 4 descendants of its own
- K182531: ClotTriever Thrombectomy System (2018), 3 descendants of its own
- K230743: ICHOR 14F Embolectomy System (2023), 0 descendants of its own
- K192332: ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath (2019), 0 descendants of its own

## Indications for use
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. 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/K163549
Methodology: https://510kreport.com/methodology