# K042074: Vanguard Reprocessed Diagnostic Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Mar 9, 2005 after 219 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 K022380 (2002). 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)
- K022380: Livesire Electrophysiology Catheter, St Jude Medical (2002) Summary page 1.

## Recalls of this device
- Oct 6, 2016 · Class II · Z-0380-2017: The EP Catheters may be mislabeled for French size during reprocessing.

## Indications for use
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Source page: https://510kreport.com/device/K042074
Methodology: https://510kreport.com/methodology