# K160242: Reprocessed Livewire Steerable Diagnostic EP Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: May 10, 2016 after 99 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: 2 generations back to K913940 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102721: Livewire Electophysiology Catheter, St Jude Medical (2010) Summary page 5.
- K022380: Livesire Electrophysiology Catheter, St Jude Medical (2002) Summary page 5.

## Most influential descendants
- K190127: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter (2019), 0 descendants of its own

## Indications for use
The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Source page: https://510kreport.com/device/K160242
Methodology: https://510kreport.com/methodology