510(k) K253205
K253205 is an FDA 510(k) premarket notification submitted by Cortex, Inc. for the device "OptiMap Catheter - 50mm (OPTI-CATH2-50)". The FDA issued a decision of Substantially Equivalent on March 13, 2026. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. Cortex, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2026
- Date Received
- September 26, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intracardiac Mapping, High-Density Array
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type