# K101839: Kaneka Pharma America Xpress-Way RX

- Pathway: 510(k) (Traditional)
- Applicant: Kaneka Pharma America, LLC
- Decided: Oct 22, 2010 after 113 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K213166: Thrombuster II Aspiration Catheter (2021), 0 descendants of its own

## Indications for use
The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Xpress-Way RX is not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K101839
Methodology: https://510kreport.com/methodology