# K193237: Carto Octaray Mapping Catheter with Trueref Technology

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jul 31, 2020 after 249 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.
2 later devices descend from it; 1 cites it directly.
0 of 15 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 4.

## Most influential descendants
- K211438: OPTRELL Mapping Catheter with TRUEref Technology (2022), 1 descendant of its own
- K230253: OPTRELL™ Mapping Catheter with TRUEref™ Technology (2023), 0 descendants of its own

## Indications for use
The CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology 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 catheter provides location information only when used with compatible versions of the CARTO® 3 EP Navigation System.

Source page: https://510kreport.com/device/K193237
Methodology: https://510kreport.com/methodology