Cleared Traditional

OptiMap Catheter - 50mm (OPTI-CATH2-50)

K253205 · Cortex, Inc. · Cardiovascular

Mar 2026

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K253205 is an FDA 510(k) clearance for the OptiMap Catheter - 50mm (OPTI-CATH2-50), a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Cortex, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 13, 2026, 168 days after receiving the submission on September 26, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K253205 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	March 13, 2026
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF