# K030109: Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Aug 8, 2003 after 207 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992965 (1999). 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)
- K992965: Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085, Cordis Webster, Inc. (1999) Summary page 6.

## Recalls of this device
- Oct 18, 2013 · Class II · Z-0340-2014: Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.

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

Source page: https://510kreport.com/device/K030109
Methodology: https://510kreport.com/methodology