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Cortex, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K261012
OptiMap Catheter - 60mm (OPTI-CATH2-60)
April 23, 2026
K253205
OptiMap Catheter - 50mm (OPTI-CATH2-50)
March 13, 2026