# K983456: Ensite 3000 System

- Pathway: 510(k) (Traditional)
- Applicant: Endocardial Solutions, Inc.
- Decided: Apr 21, 1999 after 203 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) EP Technologies, Inc. Asymmetric Curve Steerocath: named in the summary without a submission number
- (no number) Biosense CARTO System: named in the summary without a submission number

## Most influential descendants
- K121006: Ensite Array Multi-Electrode Diagnostic Catheter (2012), 0 descendants of its own

## Indications for use
The EnSite Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysioclogy 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/K983456
Methodology: https://510kreport.com/methodology