OptiMap Catheter - 50mm (OPTI-CATH2-50)— 510(k) K253205
Substantially EquivalentCortex, Inc.
FDA 510(k) clearance K253205 for OptiMap Catheter - 50mm (OPTI-CATH2-50), Substantially Equivalent on 2026-03-13. Applicant: Cortex, Inc.. Device class: 2.
Summary
Cortex's OptiMap Catheter - 50mm (OPTI-CATH2-50) is filed under MTD, high-density array intracardiac mapping catheters. The record lists only the 50mm version given in the name.
Class II, 21 CFR 870.1220. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Cortex filed from Santa Clara, California. The decision came 168 calendar days after receipt (September 26, 2025 to March 13, 2026).
Clearance details
- Applicant
- Cortex, Inc.
- Product code
- Product code MTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code MTD
view all- K261012 — OptiMap Catheter - 60mm (OPTI-CATH2-60)
- K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)
- K241372 — Advisor HD Grid X Mapping Catheter, Sensor Enabled
- K231312 — PENTARAY® 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 ID
- K223666 — Ablacath Mapping Catheter
Adverse events under product code MTD
product code MTD- Death
- 22
- Injury
- 376
- Malfunction
- 986
- Total
- 1,384
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.