# K212959: ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 15, 2021 after 29 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
Longest line of descent: 4 generations back to K081808 (2008). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203726: ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter, Siemens Medical Solutions USA, Inc. (2021) Summary page 4.

## Most influential descendants
- K242893: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (2025), 2 descendants of its own
- K261696: ACUNAV Luxera 4D ICE Catheter (2026), 0 descendants of its own
- K261849: VERAFEYE Imaging Catheter (VF-VIC-002) (2026), 0 descendants of its own
- K260885: VERAFEYE Imaging and Guidance System (VF-VIS-002) (2026), 0 descendants of its own

## Indications for use
The catheter is intended for intracardiac 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. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Source page: https://510kreport.com/device/K212959
Methodology: https://510kreport.com/methodology