# K982540: Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array Deployment Kit,

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Pathways Corp.
- Decided: Jan 27, 1999 after 190 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) Woven Dacron® Electrode Catheters: named in the summary without a submission number
- (no number) Atrial Mapping Electrode Catheters: named in the summary without a submission number
- (no number) Explorer ST™ Fixed Curve Diagnostic Catheter: named in the summary without a submission number
- (no number) Fixed Tip Electrophysiology Catheters: named in the summary without a submission number
- (no number) Deflectable Halo Electrophysiology Catheters: named in the summary without a submission number

## Most influential descendants
- K990795: Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter Cables (1999), 0 descendants of its own

## Indications for use
The Mercator Atrial High-Density Array Catheter, used in conjunction with the Cardiac Pathways’ Model 8100 Arrhythmia Mapping System and the Model 8300 Signal Acquisition Module, 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). The system is used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.

Source page: https://510kreport.com/device/K982540
Methodology: https://510kreport.com/methodology