# K230356: Aspirex™ Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 31, 2023 after 50 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: 10 generations back to K003410 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220270: Aspirex Thrombectomy System, C.R. Bard, Inc. (2022) Summary page 4.

## Indications for use
The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system. The 6F and 8F Aspirex™ Thrombectomy Systems are indicated for the removal of acute emboli and thrombi from hemodialysis access grafts and native arteriovenous fistulas.

Source page: https://510kreport.com/device/K230356
Methodology: https://510kreport.com/methodology