# K123482: Reflow Aspiration Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Apr 29, 2013 after 167 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lumen Medical Xtract Aspiration Catheter: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K123482
Methodology: https://510kreport.com/methodology