# K042850: Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Aug 9, 2006 after 663 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 1.

## Indications for use
The Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping 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 catheter through the coronary vasculature nor the coronary sinus.

Source page: https://510kreport.com/device/K042850
Methodology: https://510kreport.com/methodology