# K112382: Terumo Aspriation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Dec 14, 2011 after 118 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: 6 generations back to K010579 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter,, Vascular Solutions, Inc. (2009) Summary page 5.
- K061958: Medtronic Export XT Catheter, Medtronic Vascular (2006) Summary page 5.

## Indications for use
The Terumo Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K112382
Methodology: https://510kreport.com/methodology