# K061045: Reprocessed Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Aug 31, 2006 after 139 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- 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 K915563 (1992). 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)
- K915563: Diagnostic EP Catheter, Arrhythmia Technologies, Inc. (1992) Summary page 1.

## Indications for use
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Source page: https://510kreport.com/device/K061045
Methodology: https://510kreport.com/methodology