# K213166: Thrombuster II Aspiration Catheter

- Pathway: 510(k) (Special)
- Applicant: Kaneka Medical America, LLC
- Decided: Oct 26, 2021 after 28 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
Longest line of descent: 1 generation back to K101839 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101839: Kaneka Pharma America Xpress-Way RX, Kaneka Pharma America, LLC (2010) Summary page 4.

## Indications for use
The Thrombuster II Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Thrombuster II is not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K213166
Methodology: https://510kreport.com/methodology