# K992631: Acunav Diagnostic Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acuson Corp.
- Decided: Dec 15, 1999 after 131 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- 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: 1 generation back to K921148 (1992). 2 ancestors in all.
1,093 later devices descend from it; 9 cite it directly.
3 of 1,096 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/, Cardiovascular Imaging Systems, Inc. (1997) Summary page 2.
- K921148: Cvis Insight Catheters for Intracardiac Use, Cardiovascular Imaging Systems, Inc. (1992) Summary page 2.

## Most influential descendants
- K022567: Sequoia Signature II Diagnostic Ultrasound System (2002), 1,069 descendants of its own
- K032114: Sequoia 8.0 Diagnostic Ultrasound System (2003), 1,003 descendants of its own
- K041319: Sequoia Diagnostic Ultrasound System (2004), 988 descendants of its own
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own
- K052410: Acuson Sequoia Ultrasound System (2005), 972 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
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The AcuNav™ 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 AcuNav™ is intended for use in right heart only. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The AcuNav™ 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 AcuNav™ is intended for use in right heart only.

Source page: https://510kreport.com/device/K992631
Methodology: https://510kreport.com/methodology