# K201806: Reprocessed PentaRay Nav eco High-Density Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed Inc. (Johnson and Johnson)
- Decided: Jun 23, 2021 after 357 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- 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. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with 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/K201806
Methodology: https://510kreport.com/methodology