# K991878: Luma-Cath Steerable EP Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Biomedical, Inc.
- Decided: Dec 10, 1999 after 191 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
Longest line of descent: 1 generation back to K961924 (1997). 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)
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1997). Our OCR of the scanned summary read “K961924” beside “510(k)”; FDA’s K961924 is the only number that fits it and carries the summary’s name for the device. Summary page 1.

## Indications for use
The IBI Luma-Cath™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the His bundle.

Source page: https://510kreport.com/device/K991878
Methodology: https://510kreport.com/methodology