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FDA 510(k)

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

K-Number: K261012 · 2026-04-23

ApplicantCortex, Inc.
Decision Date2026-04-23
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OptiMap Catheter - 60mm (OPTI-CATH2-60) is a medical device manufactured by Cortex, Inc.. It received FDA 510(k) clearance on 2026-04-23 under approval number K261012. 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 - 60mm (OPTI-CATH2-60)?

OptiMap Catheter - 60mm (OPTI-CATH2-60) is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Cortex, Inc.. The 510(k) number is K261012.

When was OptiMap Catheter - 60mm (OPTI-CATH2-60) approved by the FDA?

OptiMap Catheter - 60mm (OPTI-CATH2-60) received FDA 510(k) clearance on 2026-04-23, under approval number K261012.

What company makes OptiMap Catheter - 60mm (OPTI-CATH2-60)?

OptiMap Catheter - 60mm (OPTI-CATH2-60) is manufactured by Cortex, Inc..

What is the FDA product code for OptiMap Catheter - 60mm (OPTI-CATH2-60)?

The FDA product code for OptiMap Catheter - 60mm (OPTI-CATH2-60) is MTD.

Other Devices by Cortex, Inc.

K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)

Related Devices (Code: MTD)

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Official Source

View on FDA Database →

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

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