# K022380: Livesire Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Oct 1, 2002 after 71 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- 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
No predicates in its family tree.
73 later devices descend from it; 8 cite it directly.
9 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Electrophysiology Catheter: named in the summary without a submission number

## Most influential descendants
- K061363: Agilis NXT Steerable Introducer (2006), 53 descendants of its own
- K081645: Agilis NXT Steerable Introducer, Model G408324 (2008), 36 descendants of its own
- K102721: Livewire Electophysiology Catheter (2010), 14 descendants of its own
- K150631: St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter (2015), 12 descendants of its own
- K151622: St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter (2015), 11 descendants of its own

## Indications for use
SJM-Daig electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Source page: https://510kreport.com/device/K022380
Methodology: https://510kreport.com/methodology