# K021802: Stereotaxis Catheter Advancer System

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Apr 8, 2003 after 309 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: 1 generation back to K990271 (1999). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K990271: Endosonics Trak Back Device, Endosonics Corp. (1999) Summary page 1.
- K001992: Ilt 0.014 Catheter, Model C114NL2, Intra Luminal Therapeutics, Inc. (2000)

## Most influential descendants
- K042850: Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile) (2006), 0 descendants of its own
- K051374: Cardiodrive Catheter Advancement System (2005), 0 descendants of its own

## Indications for use
The Stereotaxis CardiodriveTM is intended for automatically advancing and retracting only the Stereotaxis TangentTM Electrophysiology Catheter (part # 001-001223-1) of 7F shaft diameter and 8F tip. The CardiodriveTM is intended to advance the Stereotaxis TangentTM Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the TangentTM Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.

Source page: https://510kreport.com/device/K021802
Methodology: https://510kreport.com/methodology