# K190785: Reprocessed PentaRay Nav eco High-Density Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Jun 25, 2019 after 90 days
- Product code: NLG (Catheter, Intracardiac Mapping, High-Density, 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: 6 generations back to K983171 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123837: Pentaray Nav Eco High-Density Mapping Catheter, Biosense Webster, Inc. (2013) Summary page 5.

## Indications for use
The Reprocessed PentaRay Nav eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. The catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The catheter provides location information when used with the compatible Carto 3 EP Navigation Systems. (This catheter is not compatible with Carto 3 EP Navigation Systems prior to Version 3.x.)

Source page: https://510kreport.com/device/K190785
Methodology: https://510kreport.com/methodology