# K182232: Octane Mechanical Thrombectomy System

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Sep 11, 2018 after 25 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: 4 generations back to K970657 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173266: Octane aspiration system, Vascular Solutions, Inc. (2017) Summary page 4.

## Indications for use
The Octane Mechanical Thrombectomy System is intended for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial and deep venous system, and to infuse/deliver diagnostic or therapeutic agents.

Source page: https://510kreport.com/device/K182232
Methodology: https://510kreport.com/methodology