# K140318: Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound Catheter

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster
- Decided: Mar 12, 2014 after 30 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SOUNDSTAR eco 10F: named in the summary without a submission number
- (no number) SOUNDSTAR eco 10FG: named in the summary without a submission number
- (no number) AcuNav UF: named in the summary without a submission number
- (no number) AcuNav SF0: named in the summary without a submission number

## Most influential descendants
- K250545: Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (2025), 0 descendants of its own
- K161700: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters (2016), 0 descendants of its own
- K142395: SC2000 and ACUSON X300 Diagnostic Ultrasound Systems (2014), 0 descendants of its own

## Recalls of this device
- Sep 10, 2015 · Class II · Z-0003-2016: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of t

## Indications for use
The Biosense Webster SOUNDSTAR® eco Diagnostic Ultrasound Catheter and related accessory devices 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, the SOUNDSTAR® eco Catheter provides location information. Please refer to the Compatibility Matrix Insert for Compatible CARTO® 3 Systems as each catheter is compatible with a specific version of CARTO® 3 and is not backwards compatible with previous versions of CARTO® 3 EP Navigation Systems.

Source page: https://510kreport.com/device/K140318
Methodology: https://510kreport.com/methodology