# K081808: Acunav V Ultrasound Catheter

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 26, 2008 after 92 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
No predicates in its family tree.
26 later devices descend from it; 2 cite it directly.
0 of 27 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) AcuNav Ultrasound Imaging Catheter: named in the summary without a submission number

## Most influential descendants
- K163478: AcuNav Volume ICE Catheter (2017), 24 descendants of its own
- K173618: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter (2017), 23 descendants of its own
- K181098: ACUSON SC2000 Diagnostic Ultrasound System (2018), 19 descendants of its own
- K191467: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (2019), 9 descendants of its own
- K200585: Acuson SC2000 Diagnostic Ultrasound System (2020), 8 descendants of its own

## Indications for use
The AcuNavTM V 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 Acuson AcuNav V 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 of adult and pediatric patients.

Source page: https://510kreport.com/device/K081808
Methodology: https://510kreport.com/methodology