FDA 510(k) clearance · back to tracker

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

Cortex, Inc. cleared K261012 on 2026-04-23, decision: substantially equivalent

K-number

K261012

Sponsor

Cortex, Inc.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-04-23

Product code

MTD

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1220

Official FDA record

Open K261012on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.