# K133396: Vdrive with V-Sono

- Pathway: 510(k) (Special)
- Applicant: Stereotaxis, Inc.
- Decided: Feb 6, 2014 after 92 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: 2 generations back to K071029 (2007). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122659: Vdrive W/V-Sono, Stereotaxis, Inc. (2013) Summary page 1.

## Most influential descendants
- 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 VdriveTrM 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-SonoTM disposable sets in the VdriveTM system. Compatible catheters include Biosense Webster, Inc. SoundstarTM 3D Ultrasound Catheters and Acuson AcuNavTM Ultrasound Catheters. Other models of ICE catheters have not been tested with the VdriveM system. VdriveTM with V-SonoTM 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/K133396
Methodology: https://510kreport.com/methodology