# K030279: Reprocessed Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Oct 3, 2003 after 249 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 K931794 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931794: Marinr Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1994) Summary page 5.
- K951347: Marinr Series EP Diagnosti Catheters, Medtronic Cardiorhythm (1995) Summary page 5.
- K981642: Stablemapr Steerable Intracardiac Catheters, Medtronic Cardiorhythm (1998) Summary page 5.

## 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/K030279
Methodology: https://510kreport.com/methodology