# K040751: Vanguard Reprocessed Diagnostic Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Mar 10, 2005 after 351 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Cordis Webster Diagnostic 7F Deflectable Tip Catheter: named in the summary without a submission number
- (no number) Corits Webster Orthogonal Catheter: named in the summary without a submission number

## Indications for use
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. In addition, the preformed shape of the Halo XP catheter's tip section is designed particularly for the tricuspid annulus.

Source page: https://510kreport.com/device/K040751
Methodology: https://510kreport.com/methodology