# K183027: Steerable catheter control system

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Sep 6, 2019 after 309 days
- Product code: PJB (Catheter Remote Control System)
- Device class: 2
- Regulation: 21 CFR 870.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900765 (1990). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140009: Amigo Remote Catheter System, Catheter Robotics, Inc. (2014). Our reading of the summary gave K140394, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN140009, Amigo Remote Catheter System (Catheter Robotics, Inc.), granted Dec 18, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K051760: Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05, Stereotaxis, Inc. (2006) Summary page 4.
- K060967: Niobe Magnetic Navigation System W/Navigant Workstation, Stereotaxis, Inc. (2006) Summary page 4.
- K071029: Cardiodrive Catheter Advancement System (Cas), Stereotaxis, Inc. (2007) Summary page 4.

## Most influential descendants
- K192775: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (2019), 1 descendant of its own
- K193147: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (2020), 0 descendants of its own

## Indications for use
The Niobe System is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. The Cardiodrive Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient’s heart when used in conjunction with a Stereotaxis MNS. The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus. The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

Source page: https://510kreport.com/device/K183027
Methodology: https://510kreport.com/methodology