# K180710: Reprocessed DecaNav Diagnostic Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Jun 19, 2018 after 92 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 K841802 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080425: CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02, Biosense Webster, Inc. (2008) Summary page 5.

## Indications for use
The Reprocessed DecNav Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the Coronary Sinus. The catheter provides tip location information when used with the compatible Carto 3 EP Navigation Systems.

Source page: https://510kreport.com/device/K180710
Methodology: https://510kreport.com/methodology