# K161700: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Nov 21, 2016 after 154 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: 5 generations back to K921148 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140318: Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound Catheter, Biosense Webster (2014) Summary page 5.
- K110076: Reprocessed 3D Diagnostic Ultrasound Catheter, Sterilmed, Inc. (2011) Summary page 5.

## Indications for use
The Reprocessed 3D Diagnostic Ultrasound eco Catheters are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible Carto® 3 EP Navigation Systems (version 2.3 and higher) the reprocessed 3D Diagnostic Ultrasound eco Catheters provide location information.

Source page: https://510kreport.com/device/K161700
Methodology: https://510kreport.com/methodology