# K033211: Ensite System

- Pathway: 510(k) (Special)
- Applicant: Endocardial Solutions, Inc.
- Decided: Oct 30, 2003 after 27 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: 3 generations back to K001437 (2000). 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)
- K030129: Modification to Ensite 3000 System, Model EE3000, Endocardial Solutions, Inc. (2003)

## 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/K033211
Methodology: https://510kreport.com/methodology