# K233825: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health
- Decided: Jun 7, 2024 after 189 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: 5 generations back to K050877 (2005). 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)
- K101991: Webster Duo-Decapolar  Catheter, Biosense Webster, Inc. (2011) Summary page 6.
- K190980: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter, Innovative Health, LLC (2019) Summary page 6.

## Indications for use
The Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.

Source page: https://510kreport.com/device/K233825
Methodology: https://510kreport.com/methodology