# K170474: Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Jun 16, 2017 after 120 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: 6 generations back to K921148 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101138: Soundstar 3D Ultrasound Catheter Model M-5723-12, Biosense Webster, Inc. (2010) Summary page 5.
- K091352: Soundstar 3D Diagnostic Catheter, Model M-5723-05, Biosense Webster, Inc. (2009) Summary page 5.

## Indications for use
The Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is 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 SoundStar 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO EP Navigation Systems.

Source page: https://510kreport.com/device/K170474
Methodology: https://510kreport.com/methodology