# K062192: Ostial Pro Stent Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Ostial Solutions, LLC
- Decided: May 24, 2007 after 297 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: 4 generations back to K970376 (1997). 16 ancestors in all.
35 later devices descend from it; 4 cite it directly.
5 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994358: Atw Marker Wire Steerable Guidewire, Cordis Corp. (2000) Summary page 1.
- K042338: Coronary Peripheral and Renal Steerable Guidewire, Lake Region Mfg., Inc. (2004) Summary page 1.
- K031864: Nitrex Nitinol Guidewire, Ev3 Corporation (2003) Summary page 1.
- K061171: Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX, Biosphere Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K100292: Caas Qva 3D, Caas Qca 3D (2010), 13 descendants of its own
- K091781: Guided Medical Positioning System (GMPS) (2009), 11 descendants of its own
- K133993: Caas Workstation (2014), 10 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/K062192
Methodology: https://510kreport.com/methodology