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510(k) K261012

OptiMap Catheter - 60mm (OPTI-CATH2-60) by Cortex, Inc. — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2026
Date Received
March 27, 2026
Clearance Type
Special
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

Other clearances by Cortex, Inc.

  • K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50) (March 13, 2026)

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