# K261012: OptiMap Catheter - 60mm (OPTI-CATH2-60)

- Pathway: 510(k) (Special)
- Applicant: Cortex, Inc.
- Decided: Apr 23, 2026 after 27 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253205: OptiMap Catheter - 50mm (OPTI-CATH2-50), Cortex, Inc. (2026) Summary page 5.

## Indications for use
The OptiMapT-r Catheter is indicated for use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters). The OptiMapT-r Catheter may also be used for delivery of externally generated pacing stimuli.

Source page: https://510kreport.com/device/K261012
Methodology: https://510kreport.com/methodology