# K965066: Arrhythmia Mapping System (8100/8300)

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Pathways Corp.
- Decided: Aug 11, 1997 after 236 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Arrhythmia Mapping System is intended to be used to record, view, and analyze intracardiac electrogram (EGM) and surface electrocardiograph (EKG) signals. By performing these functions, the Mapping System assists in the collection and presentation of signal information necessary for the diagnosis and localization of cardiac arrhythmias. The system1s intended to be uséd by a Cardiologist (subspecialty Cardiac Electrophysiology) during electrophysiology studies.

Source page: https://510kreport.com/device/K965066
Methodology: https://510kreport.com/methodology