# K990795: Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter Cables

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Pathways Corp.
- Decided: Jun 8, 1999 after 90 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 K982540 (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)
- K982540: Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array Deployment Kit,, Cardiac Pathways Corp. (1999) Summary page 1.

## Indications for use
The Mercator Atrial High Density Array Catheter 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). When used in conjunction with electrogram recording equipment and stimulators, 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. The Mercator Atrial High Density Array Catheter can be used with: o the Cardiac Pathways’ Model 8100 Arrhythmia Mapping System and the Model 8300 Signal Acquisition Module in conjunction with a stimulator, and o Cardiac Pathways’ EGM Adapter Cables (Models 2036, 2043, and 2044) in conjunction with intracardiac electrogram recording equipment.

Source page: https://510kreport.com/device/K990795
Methodology: https://510kreport.com/methodology