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FDA 510(k)

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

K-Number: K253205 · 2026-03-13

ApplicantCortex, Inc.
Decision Date2026-03-13
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OptiMap Catheter - 50mm (OPTI-CATH2-50) is the device name listed in this FDA 510(k) record. The listed applicant is Cortex, Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) 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. The listed applicant is Cortex, Inc.. The 510(k) number is K253205.

When did OptiMap Catheter - 50mm (OPTI-CATH2-50) receive FDA 510(k) clearance?

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

Who is the listed applicant for OptiMap Catheter - 50mm (OPTI-CATH2-50)?

The FDA 510(k) record lists Cortex, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Cortex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: MTD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MedtronicK241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICALK231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.K223666Ablacath™ Mapping CatheterAblacon, Inc.K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyBiosense Webster, Inc.

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.

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