# K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 29, 2007 after 57 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.
356 later devices descend from it; 11 cite it directly.
3 of 357 devices in its family (counting itself) have 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) original AcuNav Ultrasound Imaging Catheter: named in the summary without a submission number

## Most influential descendants
- K111674: Acuson (2011), 223 descendants of its own
- K121138: Acuson S3000 Diagnostic Ultrasound System (2012), 198 descendants of its own
- K112596: Acuson S2000 Diagnostic Ultrasound System (2011), 192 descendants of its own
- K130739: Acuson S2000 and S3000 Diagnostic Ultrasound Systems (2013), 177 descendants of its own
- K131164: Acuson (2013), 124 descendants of its own

## Recalls of this device
- Mar 20, 2009 · Not classified · Z-1745-2011: Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.

## Indications for use
The Acuson Acunav Ultrsound Catheter is intended 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 of adult and pediatric patients.

Source page: https://510kreport.com/device/K071234
Methodology: https://510kreport.com/methodology