Medical Device Manufacturer · US , Santa Clara , CA

Cortex, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2026

Recent clearances: OptiMap Catheter - 60mm (OPTI-CATH2-60), OptiMap Catheter - 50mm (OPTI-CATH2-50)

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cortex, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Apr 23, 2026

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

Cardiovascular · 27d

Cleared Mar 13, 2026

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

Cardiovascular · 168d