# K030852: 4 French & 5 French Electrophysiology Diagnostic Catheters Models 5UEXXX, 5BEXXX and 5FEXXX, and 4UEXXX, 4BEXXX and 4FEX

- Pathway: 510(k) (Special)
- Applicant: Mogul Enterprises
- Decided: Jul 10, 2003 after 114 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 device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study.

Source page: https://510kreport.com/device/K030852
Methodology: https://510kreport.com/methodology