# K992479: Ensite 3000 System

- Pathway: 510(k) (Traditional)
- Applicant: Endocardial Solutions, Inc.
- Decided: Dec 2, 1999 after 129 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Endocardial Solutions EnSite 3000 System: named in the summary without a submission number

## 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 arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).

Source page: https://510kreport.com/device/K992479
Methodology: https://510kreport.com/methodology