# K122659: Vdrive W/V-Sono

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Jul 26, 2013 after 329 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K071029 (2007). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071029: Cardiodrive Catheter Advancement System (Cas), Stereotaxis, Inc. (2007) Summary page 1.

## Most influential descendants
- K140804: Vdrive with V-Loop/ Vdrive Duo (2014), 2 descendants of its own
- K133396: Vdrive with V-Sono (2014), 2 descendants of its own
- K141530: Vdrive System/ Vdrive Duo/ Vdrive with V-Cas (2014), 1 descendant of its own
- K150312: Vdrive system, Vdrive Duo, Vdrive with V-Sono (2015), 0 descendants of its own

## Indications for use
The Vdrive™ System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system. Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.

Source page: https://510kreport.com/device/K122659
Methodology: https://510kreport.com/methodology