# K121006: Ensite Array Multi-Electrode Diagnostic Catheter

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: May 3, 2012 after 30 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 K983456 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983456: Ensite 3000 System, Endocardial Solutions, Inc. (1999) Summary page 1.

## Indications for use
The EnSite Array Multi-Electrode Diagnostic Catheter, when used with 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 (i.e. linear mapping catheters).

Source page: https://510kreport.com/device/K121006
Methodology: https://510kreport.com/methodology