# K083328: Ensite System, Model EE3000, and Ensite Navx Surface Electrode, Model EN0010

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: May 22, 2009 after 191 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001437 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070902: Modification to: Ensite System, Model, EE3000, St Jude Medical (2007) Summary page 1.

## Indications for use
The EnSite System is indicated for patients for whom electrophysiology studies are indicated. * When used with the EnSite Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR * When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.

Source page: https://510kreport.com/device/K083328
Methodology: https://510kreport.com/methodology