# K033650: Acunav 90/10 Diagnostic Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 24, 2004 after 96 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
Longest line of descent: 2 generations back to K921148 (1992). 3 ancestors in all.
945 later devices descend from it; 4 cite it directly.
3 of 949 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992631: Acunav Diagnostic Ultrasound Catheter, Acuson Corp. (1999) Summary page 2.

## Most influential descendants
- K042593: Acuson Acunav 8F Ultrasound Catheter (2004), 930 descendants of its own
- K050240: Modification to Acuson CV70 Cardiovascular System (2005), 927 descendants of its own
- K052894: Sonoline G60 S Ultrasound System (2005), 926 descendants of its own
- K063138: Modification to Acuson Antares Ultrasound System (2006), 802 descendants of its own
- K063803: Acuson Antares Diagnostic Ultrasound System (2007), 801 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 AcuNavTM Diagnostic Ultrasound 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. The AcuNavTM Diagnostic Ultrasound 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. The AcuNavTM Diagnostic Ultrasound 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.

Source page: https://510kreport.com/device/K033650
Methodology: https://510kreport.com/methodology