# K012687: Vanguard Reprocessed Diagnostic Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Aug 1, 2002 after 352 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Biosense Webster Diagnostic Electrophysiology Catheters: named in the summary without a submission number
- (no number) Bard Electrophysiology Diagnostic EP Catheters: named in the summary without a submission number

## Most influential descendants
- K023180: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (2002), 1 descendant of its own
- K030114: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (2003), 0 descendants of its own

## 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/K012687
Methodology: https://510kreport.com/methodology