# K030114: Vanguard Reprocessed Diagnostic Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Mar 21, 2003 after 67 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 K924163 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002976: Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX and 401XXX, St Jude Medical (2000) Summary page 5.
- K012687: Vanguard Reprocessed Diagnostic Electrophysiology Catheters, Vanguard Medical Concepts, Inc. (2002) Summary page 5.
- K012688: Vanguard Reprocessed Diagnostic Electrophysiology Catheters, Vanguard Medical Concepts, Inc. (2002) Summary page 5.
- K022316: Vanguard Reprocessed Diagnostic Electrophysiology Catheters, Vanguard Medical Concepts, Inc. (2002)
- K023180: Vanguard Reprocessed Diagnostic Electrophysiology Catheters, Vanguard Medical Concepts, Inc. (2002)

## 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/K030114
Methodology: https://510kreport.com/methodology