# K052414: Reprocessed Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Nov 16, 2005 after 75 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: 3 generations back to K891908 (1989). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924109: Steerocath II, Ep Technologies, Inc. (1993) Summary page 1.
- K924163: Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec, Boston Scientific Corp (1993) Summary page 1.
- K003452: Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D, Ep Technologies, Inc. (2000) Summary page 1.
- K954651: Electrode Recording Catheter, Boston Scientific Corp (1996) Summary page 1.
- K012708: Electrophysiology Catheter, Alliance Medical Corp. (2002) Summary page 1.
- K043393: Reprocessed EP Technologies Electrophysiology Catheters, Alliance Medical Corp. (2005) Summary page 1.

## Indications for use
Reprocessed Diagnostic Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Source page: https://510kreport.com/device/K052414
Methodology: https://510kreport.com/methodology