# K260289: Perfect-O Ostial Positioning Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Balosmark, Inc.
- Decided: Jun 5, 2026 after 127 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K970376 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122089: Ostial Pro Stent Positioning System, Merit Medical Systems, Inc. (2012) Summary page 5.

## Indications for use
The Perfect-O Ostial Positioning Catheter is intended for use in aorto-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Perfect-O Ostial Positioning Catheter is intended to facilitate the alignment of interventional devices and function as an alignment tool. The Perfect-O Ostial Positioning Catheter is not intended for use and has not been evaluated for use in the neurovasculature.

Source page: https://510kreport.com/device/K260289
Methodology: https://510kreport.com/methodology