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510(k) K253205

OptiMap Catheter - 50mm (OPTI-CATH2-50) by Cortex, Inc. — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2026
Date Received
September 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intracardiac Mapping, High-Density Array
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

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