FDA 510(k)

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

K-Number: K253205 · 2026-03-13

Decision Date2026-03-13

Product CodeMTD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OptiMap Catheter - 50mm (OPTI-CATH2-50) is a medical device manufactured by Cortex, Inc.. It received FDA 510(k) clearance on 2026-03-13 under approval number K253205. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiMap Catheter - 50mm (OPTI-CATH2-50)?

OptiMap Catheter - 50mm (OPTI-CATH2-50) is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Cortex, Inc.. The 510(k) number is K253205.

When was OptiMap Catheter - 50mm (OPTI-CATH2-50) approved by the FDA?

OptiMap Catheter - 50mm (OPTI-CATH2-50) received FDA 510(k) clearance on 2026-03-13, under approval number K253205.

What company makes OptiMap Catheter - 50mm (OPTI-CATH2-50)?

OptiMap Catheter - 50mm (OPTI-CATH2-50) is manufactured by Cortex, Inc..

What is the FDA product code for OptiMap Catheter - 50mm (OPTI-CATH2-50)?

The FDA product code for OptiMap Catheter - 50mm (OPTI-CATH2-50) is MTD.

Other Devices by Cortex, Inc.

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)

Related Devices (Code: MTD)

K153093FIRMap CatheterAbbott Electrophysiology K170819AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K163709FIRMap CatheterAbbott Electrophysiology K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. K201341AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.