# K101138: Soundstar 3D Ultrasound Catheter Model M-5723-12

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Jun 22, 2010 after 61 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092064: Soundstar 3D Ultrasound Catheter, Model M-5723-12, Biosense Webster, Inc. (2009) Summary page 1.

## Most influential descendants
- K170474: Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter (2017), 0 descendants of its own

## Indications for use
The Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-lumninal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTo® EP Navigation Systems, the SOUNDSTAR 3D Catheter provides location information.

Source page: https://510kreport.com/device/K101138
Methodology: https://510kreport.com/methodology