# K030026: Reprocessed Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: May 2, 2003 after 119 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: 2 generations back to K891908 (1989). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894500: Daig Electrophysiology Catheter, Daig Corp. (1989) Summary page 8.
- K913940: Response (TM) Steerable Catheter, Daig Corp. (1993) Summary page 8.
- K942379: Daig Diagnostic Electrophysiology Catheter, Daig Corp. (1994) Summary page 8.
- K002976: Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX and 401XXX, St Jude Medical (2000)
- K012708: Electrophysiology Catheter, Alliance Medical Corp. (2002)

## Indications for use
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Reprocessed electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

Source page: https://510kreport.com/device/K030026
Methodology: https://510kreport.com/methodology