# K220270: Aspirex Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 21, 2022 after 141 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: 9 generations back to K003410 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192833: Indigo Aspiration System, Penumbra, Inc. (2019) Summary page 4.

## Most influential descendants
- K230356: Aspirex™ Thrombectomy System (2023), 0 descendants of its own

## Indications for use
The AspirexTM Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.

Source page: https://510kreport.com/device/K220270
Methodology: https://510kreport.com/methodology