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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intracardiac Mapping, High-Density Array
510(k) Number K253205
Device Name OptiMap Catheter - 50mm (OPTI-CATH2-50)
Applicant
Cortex, Inc.
2755 Great America Way
Suite 401
Santa Clara,  CA  95054
Applicant Contact Sarah Ware
Correspondent
Cortex, Inc.
2755 Great America Way
Suite 401
Santa Clara,  CA  95054
Correspondent Contact Sarah Ware
Regulation Number870.1220
Classification Product Code
MTD  
Date Received09/26/2025
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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