# K212632: ClotTriever Thrombectomy System

- Pathway: 510(k) (Special)
- Applicant: Inari Medical, Inc.
- Decided: Oct 18, 2021 after 60 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: 16 generations back to K901627 (1990). 25 ancestors in all.
15 later devices descend from it; 7 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210689: ClotTriever Thrombectomy System, Inari Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K223000: Artix BG (2023), 3 descendants of its own
- K230912: Artix BG (2023), 2 descendants of its own
- K223609: RevCore™ Thrombectomy Catheter. (2023), 2 descendants of its own
- K223891: Cobra Catheter System (2023), 2 descendants of its own
- K252956: Helo Thrombectomy System (2025), 1 descendant of its own

## Indications for use
The ClotTriever Thrombectomy System is indicated for: * The non-surgical removal of 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 including deep vein thrombosis (DVT).

Source page: https://510kreport.com/device/K212632
Methodology: https://510kreport.com/methodology