# K012926: Modification to Ensite 3000 System, Model EE3000

- Pathway: 510(k) (Special)
- Applicant: Endocardial Solutions, Inc.
- Decided: Sep 28, 2001 after 28 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- Device class: 2
- Regulation: 21 CFR 870.1220
- 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 K001437 (2000). 1 ancestor in all.
55 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001437: Ensite 3000 System, Model EE3000, Endocardial Solutions, Inc. (2000) Summary page 1.

## Most influential descendants
- K030129: Modification to Ensite 3000 System, Model EE3000 (2003), 54 descendants of its own
- K042493: Ensite System, Model EE3000 (2004), 52 descendants of its own
- K060954: Modification to Ensite System, Model EE3000 (2006), 51 descendants of its own
- K072202: Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01) (2007), 47 descendants of its own
- K090017: Carto 3 EP Navigation System, V1.0 and Accessories (2009), 45 descendants of its own

## Indications for use
The Ensite® Multi-electrode Diagnostic Catheter used with the Ensite 3000 Electrophysiology Workstation is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

Source page: https://510kreport.com/device/K012926
Methodology: https://510kreport.com/methodology