# K092425: Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Oct 21, 2009 after 75 days
- Product code: OWQ (Reprocessed Intravascular Ultrasound Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 K921148 (1992). 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)
- K070242: Soundstar 3D Ultrasound Catheter, Model M-5723-05, Biosense Webster, Inc. (2007) Summary page 1.

## Indications for use
Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTOO XP EP Navigation System Version 9 or greater.

Source page: https://510kreport.com/device/K092425
Methodology: https://510kreport.com/methodology