# K230253: OPTRELL™ Mapping Catheter with TRUEref™ Technology

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Mar 2, 2023 after 30 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: 8 generations back to K983171 (1999). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211438: OPTRELL Mapping Catheter with TRUEref Technology, Biosense Webster, Inc. (2022) Summary page 4.

## Indications for use
The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.c., 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 a compatible version of the CARTO™ 3 System.

Source page: https://510kreport.com/device/K230253
Methodology: https://510kreport.com/methodology