# K110076: Reprocessed 3D Diagnostic Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Aug 18, 2011 after 219 days
- Product code: OWQ (Reprocessed Intravascular Ultrasound Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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.
- K033650: Acunav 90/10 Diagnostic Ultrasound Catheter, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K161700: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters (2016), 0 descendants of its own

## Recalls of this device
- Sep 24, 2014 · Class II · Z-0059-2015: Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Steril

## Indications for use
The Reprocessed 3D Diagnostic Ultrasound 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. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO XP EP Navigation System Version 9 or greater.

Source page: https://510kreport.com/device/K110076
Methodology: https://510kreport.com/methodology