# K991025: Luma-Cath Fixed Curve EP Catheters

- Pathway: 510(k) (Special)
- Applicant: Irvine Biomedical, Inc.
- Decided: Oct 15, 1999 after 200 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. Our reading found no predicate number; beside “510(k)” the summary reads “K848333”, which our checks could not confirm as its predicate.

## Indications for use
The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for measurement of electrical activity in the heart.

Source page: https://510kreport.com/device/K991025
Methodology: https://510kreport.com/methodology