# K141530: Vdrive System/ Vdrive Duo/ Vdrive with V-Cas

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Dec 18, 2014 after 192 days
- Product code: DXX (System, Catheter Control, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K900765 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 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 5.
- K140804: Vdrive with V-Loop/ Vdrive Duo, Stereotaxis, Inc. (2014). Cleared while this submission was under review Summary page 5.
- K122659: Vdrive W/V-Sono, Stereotaxis, Inc. (2013) Summary page 5.
- K133396: Vdrive with V-Sono, Stereotaxis, Inc. (2014) Summary page 5.
- K090365: Hansen Medical Artisan S Control Catheter, Hansen Medical, Inc. (2009) Summary page 5.

## Most influential descendants
- 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 remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS). The Vdrive® with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. 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. The Vdrive® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 and Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive® system. The Vdrive® with V-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy. The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.

Source page: https://510kreport.com/device/K141530
Methodology: https://510kreport.com/methodology