# K122089: Ostial Pro Stent Positioning System

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Sep 21, 2012 after 67 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K970376 (1997). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062192: Ostial Pro Stent Positioning System, Ostial Solutions, LLC (2007) Summary page 1.

## Most influential descendants
- K260289: Perfect-O Ostial Positioning Catheter (2026), 0 descendants of its own

## Indications for use
The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents; and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.

Source page: https://510kreport.com/device/K122089
Methodology: https://510kreport.com/methodology