# K071029: Cardiodrive Catheter Advancement System (Cas)

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Aug 24, 2007 after 135 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
No predicates in its family tree.
8 later devices descend from it; 3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Cardiodrive® Catheter Advancement System: named in the summary without a submission number
- (no number) Stereotaxis Cardiodrive® Catheter Advancer System: named in the summary without a submission number
- (no number) Stereotaxis Catheter Advancement System (CAS): named in the summary without a submission number

## Most influential descendants
- K122659: Vdrive W/V-Sono (2013), 4 descendants of its own
- K183027: Steerable catheter control system (2019), 2 descendants of its own
- K140804: Vdrive with V-Loop/ Vdrive Duo (2014), 2 descendants of its own
- K133396: Vdrive with V-Sono (2014), 2 descendants of its own
- K192775: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (2019), 1 descendant of its own

## Indications for use
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.

Source page: https://510kreport.com/device/K071029
Methodology: https://510kreport.com/methodology