# K051374: Cardiodrive Catheter Advancement System

- Pathway: 510(k) (Special)
- Applicant: Stereotaxis, Inc.
- Decided: Jun 23, 2005 after 28 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 K990271 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021802: Stereotaxis Catheter Advancer System, Stereotaxis, Inc. (2003) Summary page 2.

## Indications for use
The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only the Stereotaxis Tangent® Electrophysiology Catheter of 7F shaft diameter and 8F tip. The Cardiodrive® is intended to advance the Stereotaxis Tangent® Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent® Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.

Source page: https://510kreport.com/device/K051374
Methodology: https://510kreport.com/methodology