# K052603: Reprocessed Daig Livewire Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Nov 16, 2005 after 56 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891908 (1989). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 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 1.
- K942379: Daig Diagnostic Electrophysiology Catheter, Daig Corp. (1994) Summary page 1.
- K012708: Electrophysiology Catheter, Alliance Medical Corp. (2002) Summary page 1.

## Recalls of this device
- Apr 10, 2026 · Class II · Z-2192-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2196-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2189-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2191-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2185-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2182-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2198-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2195-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2193-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2194-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2183-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2197-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2177-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2186-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2187-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2176-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2175-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2178-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2179-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2181-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2199-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2184-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2180-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2174-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2190-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2188-2026: Incomplete seals on sterile product

## 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/K052603
Methodology: https://510kreport.com/methodology